Trial Outcomes & Findings for A Study of SHR-1210 in Combination With Apatinib in Advanced Non-Small Cell Lung Cancer(NSCLC) (NCT NCT03083041)
NCT ID: NCT03083041
Last Updated: 2026-03-03
Results Overview
Number of participants with Adverse Events and Serious Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
210 participants
Primary outcome timeframe
from signing the informed consent form to safety follow-up, 61 months
Results posted on
2026-03-03
Participant Flow
Participant milestones
| Measure |
Driver Gene Negative Population
Apatinib 250 mg + Camrelizumab 200 mg
|
Driver Gene Positive Population
Apatinib 250 mg + Camrelizumab 200 mg
|
Cohort 4
Apatinib 250 mg + Camrelizumab 200 mg
|
Apatinib 375 mg Group
Apatinib 375mg + Camrelizumab 200 mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
130
|
43
|
25
|
12
|
|
Overall Study
Treated
|
130
|
43
|
25
|
12
|
|
Overall Study
COMPLETED
|
75
|
25
|
13
|
1
|
|
Overall Study
NOT COMPLETED
|
55
|
18
|
12
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of SHR-1210 in Combination With Apatinib in Advanced Non-Small Cell Lung Cancer(NSCLC)
Baseline characteristics by cohort
| Measure |
Driver Gene Negative Population
n=130 Participants
Apatinib 250 mg + Camrelizumab 200 mg
|
Driver Gene Positive Population
n=43 Participants
Apatinib 250 mg + Camrelizumab 200 mg
|
Cohort 4
n=25 Participants
Apatinib 250 mg + Camrelizumab 200 mg
|
Apatinib 375 mg Group
n=12 Participants
Apatinib 375 mg + Camrelizumab 200 mg
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.0 years
n=41 Participants
|
55.0 years
n=35 Participants
|
61.0 years
n=76 Participants
|
55.5 years
n=565 Participants
|
59 years
n=196 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
6 Participants
n=76 Participants
|
2 Participants
n=565 Participants
|
54 Participants
n=196 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
19 Participants
n=76 Participants
|
10 Participants
n=565 Participants
|
156 Participants
n=196 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Race (NIH/OMB)
Asian
|
130 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
25 Participants
n=76 Participants
|
12 Participants
n=565 Participants
|
210 Participants
n=196 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Region of Enrollment
China
|
130 participants
n=41 Participants
|
43 participants
n=35 Participants
|
25 participants
n=76 Participants
|
12 participants
n=565 Participants
|
210 participants
n=196 Participants
|
PRIMARY outcome
Timeframe: from signing the informed consent form to safety follow-up, 61 monthsNumber of participants with Adverse Events and Serious Adverse Events
Outcome measures
| Measure |
Driver Gene Negative Population
n=130 Participants
Apatinib 250 mg + Camrelizumab 200 mg
|
Driver Gene Positive Population
n=43 Participants
Apatinib 250 mg + Camrelizumab 200 mg
|
Cohort 4
n=25 Participants
Apatinib 250 mg + Camrelizumab 200 mg
|
Apatinib 375 mg Group
n=12 Participants
Apatinib 375 mg + Camrelizumab 200 mg
|
|---|---|---|---|---|
|
Incidence and Grade of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Subjects with SAEs
|
82 participants
|
21 participants
|
9 participants
|
7 participants
|
|
Incidence and Grade of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Subjects with AEs
|
130 participants
|
43 participants
|
25 participants
|
12 participants
|
PRIMARY outcome
Timeframe: from first administration to progressive disease or initiation of new anti-cancer therapy, 61 monthsPopulation: The primary efficacy endpoint was analyzed in FAS.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Driver Gene Negative Population
n=130 Participants
Apatinib 250 mg + Camrelizumab 200 mg
|
Driver Gene Positive Population
n=43 Participants
Apatinib 250 mg + Camrelizumab 200 mg
|
Cohort 4
n=25 Participants
Apatinib 250 mg + Camrelizumab 200 mg
|
Apatinib 375 mg Group
n=12 Participants
Apatinib 375 mg + Camrelizumab 200 mg
|
|---|---|---|---|---|
|
Objective Response Rate (ORR)：
|
28.5 Percentage of participants
Interval 20.9 to 37.0
|
18.6 Percentage of participants
Interval 8.4 to 33.4
|
40.0 Percentage of participants
Interval 21.1 to 61.3
|
16.7 Percentage of participants
Interval 2.1 to 48.4
|
Adverse Events
Apatinib 250 mg Group
Serious events: 112 serious events
Other events: 197 other events
Deaths: 48 deaths
Apatinib 375 mg Group
Serious events: 7 serious events
Other events: 12 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Apatinib 250 mg Group
n=198 participants at risk
Apatinib 250 mg + Camrelizumab 200 mg
|
Apatinib 375 mg Group
n=12 participants at risk
Apatinib 375 mg + Camrelizumab 200 mg
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
4.0%
8/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.5%
5/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
5/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.5%
5/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.0%
4/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.0%
2/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
2/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
General disorders
Death
|
5.1%
10/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Acquired tracheo-oesophageal fistula
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
9.6%
19/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.0%
4/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
General disorders
Pyrexia
|
2.0%
4/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
General disorders
Asthenia
|
1.0%
2/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
General disorders
Pain
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
General disorders
Sudden death
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
5.6%
11/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
1.0%
2/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Hepatobiliary disorders
Hepatic failure
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Infections and infestations
Pneumonia
|
4.0%
8/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Infections and infestations
Focal peritonitis
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Infections and infestations
Pharyngitis
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Small intestinal perforation
|
1.0%
2/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Ileus
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Volvulus
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Acute pancreatitis
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Immune-mediated pancreatitis
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Vomiting
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Oesophagomediastinal fistula
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Gastritis
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.0%
4/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.0%
2/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Vascular disorders
Hypertension
|
2.0%
4/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Vascular disorders
Haemorrhage
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Vascular disorders
Venous thrombosis
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Vascular disorders
Circulatory collapse
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Nervous system disorders
Cerebral infarction
|
1.5%
3/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Nervous system disorders
Facial paralysis
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Nervous system disorders
Altered state of consciousness
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Nervous system disorders
Syncope
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Nervous system disorders
Tremor
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
3/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Aspartate aminotransferase increased
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Platelet count decreased
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Injury, poisoning and procedural complications
Heart injury
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Immune system disorders
Reactive capillary endothelial proliferation
|
2.0%
4/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Endocrine disorders
Immune-mediated hypophysitis
|
1.0%
2/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Endocrine disorders
Hypothyroidism
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Endocrine disorders
Adrenal insufficiency
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Cardiac disorders
Acute left ventricular failure
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Cardiac disorders
Myocardial ischemia
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Cardiac disorders
Cardiac failure
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Renal and urinary disorders
Acute kidney injury
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Eye disorders
Blindness
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
Other adverse events
| Measure |
Apatinib 250 mg Group
n=198 participants at risk
Apatinib 250 mg + Camrelizumab 200 mg
|
Apatinib 375 mg Group
n=12 participants at risk
Apatinib 375 mg + Camrelizumab 200 mg
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
39.4%
78/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
33.3%
4/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Cardiac disorders
Sinus tachycardia
|
3.5%
7/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Cardiac disorders
Cardiac failure
|
1.5%
3/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.5%
3/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Cardiac disorders
Palpitations
|
1.0%
2/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Ear and labyrinth disorders
Tinnitus
|
1.5%
3/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Endocrine disorders
Hypothyroidism
|
15.7%
31/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Diarrhoea
|
25.3%
50/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
25.0%
3/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Mouth ulceration
|
17.7%
35/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
33.3%
4/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Vomiting
|
15.7%
31/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Constipation
|
14.1%
28/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Nausea
|
11.6%
23/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
25.0%
3/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.6%
15/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Toothache
|
8.1%
16/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Gingival bleeding
|
5.6%
11/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Dry mouth
|
5.1%
10/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
4.5%
9/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Abdominal distension
|
5.1%
10/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Gastritis
|
2.5%
5/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.0%
4/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Retching
|
1.5%
3/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Gastrointestinal disorders
Haematochezia
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
General disorders
Asthenia
|
35.4%
70/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
58.3%
7/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
General disorders
Pyrexia
|
28.3%
56/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
50.0%
6/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
General disorders
Chest discomfort
|
15.2%
30/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
General disorders
Chest pain
|
9.1%
18/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
25.0%
3/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
General disorders
Oedema peripheral
|
7.1%
14/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
General disorders
Pain
|
5.6%
11/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
General disorders
Peripheral swelling
|
1.0%
2/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
14.1%
28/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Immune system disorders
Reactive capillary endothelial proliferation
|
24.2%
48/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Infections and infestations
Upper respiratory tract infection
|
12.6%
25/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Infections and infestations
Nasopharyngitis
|
7.6%
15/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
25.0%
3/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Infections and infestations
Pneumonia
|
5.1%
10/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Infections and infestations
Urinary tract infection
|
4.0%
8/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Infections and infestations
Bronchitis
|
0.00%
0/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Aspartate aminotransferase increased
|
53.5%
106/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
66.7%
8/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Alanine aminotransferase increased
|
44.9%
89/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
58.3%
7/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Neutrophil count decreased
|
28.8%
57/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
41.7%
5/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
White blood cell count decreased
|
29.3%
58/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
33.3%
4/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Blood bilirubin increased
|
27.3%
54/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
33.3%
4/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Platelet count decreased
|
22.7%
45/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
25.0%
3/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Weight decreased
|
20.7%
41/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
50.0%
6/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Gamma-glutamyltransferase increased
|
20.7%
41/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Bilirubin conjugated increased
|
15.7%
31/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
41.7%
5/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Blood thyroid stimulating hormone increased
|
15.2%
30/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
25.0%
3/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Blood creatinine increased
|
15.7%
31/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Blood alkaline phosphatase increased
|
14.6%
29/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Occult blood positive
|
10.6%
21/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Blood glucose increased
|
9.1%
18/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Urinary occult blood positive
|
8.6%
17/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Amylase increased
|
5.6%
11/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
25.0%
3/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Blood bilirubin unconjugated increased
|
6.1%
12/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Blood pressure increased
|
5.6%
11/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
4.5%
9/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Lymphocyte count decreased
|
5.1%
10/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
White blood cell count increased
|
4.5%
9/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Neutrophil count increased
|
3.5%
7/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Blood potassium decreased
|
2.5%
5/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Urobilinogen urine increased
|
2.5%
5/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Blood chloride decreased
|
1.5%
3/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Blood sodium decreased
|
1.5%
3/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Blood albumin decreased
|
1.0%
2/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Blood calcium decreased
|
1.0%
2/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Urine bilirubin increased
|
1.0%
2/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
66/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
75.0%
9/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.1%
28/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.6%
25/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.1%
22/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
11.1%
22/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.6%
21/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
9.6%
19/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.1%
16/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
7.1%
14/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
6.1%
12/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
5.6%
11/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.2%
34/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
21/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
25.0%
3/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.6%
15/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.5%
3/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.0%
2/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Nervous system disorders
Headache
|
19.7%
39/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
25.0%
3/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Nervous system disorders
Dizziness
|
9.1%
18/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Psychiatric disorders
Insomnia
|
10.6%
21/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
25.0%
3/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Renal and urinary disorders
Proteinuria
|
63.1%
125/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
75.0%
9/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Renal and urinary disorders
Haematuria
|
15.2%
30/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Renal and urinary disorders
Renal impairment
|
2.5%
5/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.8%
63/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
50.0%
6/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
22.7%
45/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
33.3%
4/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
20.7%
41/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
16.2%
32/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.6%
21/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
33.3%
4/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.1%
10/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.0%
8/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
1.5%
3/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
16.7%
2/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
42.4%
84/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
50.0%
6/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
66/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
91.7%
11/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.6%
19/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
0.00%
0/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.0%
2/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.51%
1/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
8.3%
1/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
|
Vascular disorders
Hypertension
|
63.6%
126/198 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
83.3%
10/12 • from signing the informed consent form to safety follow-up, 61 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER