Trial Outcomes & Findings for Efficacy and Safety Evaluation of IBI308 in Treatment of Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma (NCT NCT03114683)
NCT ID: NCT03114683
Last Updated: 2020-12-07
Results Overview
Per Revised International Working Group Response Criteria for Malignant Lymphoma in 2007(IWG 2007) assessed by CT and PET: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), ≥50% decrease in SPD of up to 6 largest dominant masses, no increase in size of other nodes; Overall Response (OR) = CR + PR
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2020-12-07
Participant Flow
Update analysis data cutoff date of safety data: 30 Sep, 2019. Update analysis data cutoff date of efficacy data: 12 Feb, 2018.
Participant milestones
| Measure |
Sintilimab
Subjects received sintilimab 200mg by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 2 years
|
|---|---|
|
Overall Study
STARTED
|
96
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Evaluation of IBI308 in Treatment of Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Sintilimab
n=96 Participants
Subjects received sintilimab 200mg by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 2 years
|
|---|---|
|
Age, Continuous
|
35.83 Years
STANDARD_DEVIATION 10.884 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
96 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
96 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPer Revised International Working Group Response Criteria for Malignant Lymphoma in 2007(IWG 2007) assessed by CT and PET: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), ≥50% decrease in SPD of up to 6 largest dominant masses, no increase in size of other nodes; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Sintilimab
n=96 Participants
Subjects received sintilimab 200mg by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 2 years
|
|---|---|
|
Objective Response Rate (ORR) Assessed According to the Revised International Working Group Response Criteria for Malignant Lymphoma in 2007(IWG 2007) by the Independent Radiological Review Committee (IRRC).
|
85.4 percentage of participants
Interval 76.7 to 91.8
|
Adverse Events
Sintilimab
Serious events: 24 serious events
Other events: 96 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Sintilimab
n=96 participants at risk
Subjects received sintilimab 200mg by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 2 years
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.3%
7/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Lung infection
|
3.1%
3/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Pneumonia
|
2.1%
2/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
2/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Localised infection
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Necrotising fasciitis
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Skin bacterial infection
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
General disorders
Death
|
2.1%
2/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
General disorders
Chest pain
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
General disorders
Mass
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
General disorders
Pyrexia
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Cardiac disorders
Autoimmune myocarditis
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Cardiac disorders
Cardiac failure
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Cardiac disorders
Sinus tachycardia
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Endocrine disorders
Hyperthyroidism
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Endocrine disorders
Thyroiditis
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Myocardial necrosis marker increased
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Platelet count decreased
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
1.0%
1/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
Other adverse events
| Measure |
Sintilimab
n=96 participants at risk
Subjects received sintilimab 200mg by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 2 years
|
|---|---|
|
Investigations
Blood thyroid stimulating hormone increased
|
32.3%
31/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Alanine aminotransferase increased
|
29.2%
28/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Lymphocyte count decreased
|
27.1%
26/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Neutrophil count decreased
|
20.8%
20/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Weight increased
|
19.8%
19/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
White blood cell count decreased
|
19.8%
19/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Aspartate aminotransferase increased
|
18.8%
18/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Blood uric acid increased
|
15.6%
15/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Gamma-glutamyltransferase increased
|
15.6%
15/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Platelet count decreased
|
15.6%
15/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Thyroxine free decreased
|
15.6%
15/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Blood lactate dehydrogenase increased
|
12.5%
12/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Blood glucose increased
|
11.5%
11/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Blood urine present
|
11.5%
11/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Lipase increased
|
11.5%
11/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Blood bilirubin increased
|
9.4%
9/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Weight decreased
|
9.4%
9/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Bilirubin conjugated increased
|
8.3%
8/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Neutrophil count increased
|
8.3%
8/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Protein urine present
|
8.3%
8/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Blood creatine phosphokinase increased
|
7.3%
7/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
White blood cell count increased
|
7.3%
7/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
White blood cells urine positive
|
7.3%
7/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
6/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
C-reactive protein increased
|
6.2%
6/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Electrocardiogram T wave abnormal
|
6.2%
6/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Haemoglobin decreased
|
6.2%
6/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Lymphocyte percentage decreased
|
6.2%
6/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Blood albumin decreased
|
5.2%
5/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Blood creatinine increased
|
5.2%
5/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Haemoglobin increased
|
5.2%
5/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Tri-iodothyronine decreased
|
5.2%
5/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Tri-iodothyronine free increased
|
5.2%
5/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
General disorders
Pyrexia
|
54.2%
52/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
General disorders
Asthenia
|
6.2%
6/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
General disorders
Chills
|
5.2%
5/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Upper respiratory tract infection
|
28.1%
27/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Urinary tract infection
|
14.6%
14/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Lung infection
|
7.3%
7/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.3%
7/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
18.8%
18/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.5%
13/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
6/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
9.4%
9/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.3%
7/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.2%
5/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.2%
5/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.2%
5/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.2%
5/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
8/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
7/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
6/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Endocrine disorders
Hypothyroidism
|
21.9%
21/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Endocrine disorders
Hyperthyroidism
|
10.4%
10/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.6%
14/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.3%
7/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Blood and lymphatic system disorders
Anaemia
|
14.6%
14/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Cardiac disorders
Sinus tachycardia
|
6.2%
6/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Cardiac disorders
Sinus bradycardia
|
5.2%
5/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Renal and urinary disorders
Proteinuria
|
10.4%
10/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Psychiatric disorders
Insomnia
|
6.2%
6/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Vascular disorders
Hypertension
|
6.2%
6/96 • Cutoff date of 30 Sep,2019 Serious AEs: Up to 90 days after last administration of investigation products Other AEs: Up to 90 days after last administration of investigation products
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place