Trial Outcomes & Findings for Evaluate the Efficacy and Safety of IBI305 in Patients With Advanced or Recurrent Non-squamous NSCLC (NCT NCT02954172)
NCT ID: NCT02954172
Last Updated: 2020-12-08
Results Overview
ORR（objective response rate）was defined as the percentage of participants in the analysis population who had a Complete Response or a Partial Response per RECIST 1.1. The percentage of participants who experienced a CR or PR is presented. Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
450 participants
Primary outcome timeframe
18 weeks
Results posted on
2020-12-08
Participant Flow
Participant milestones
| Measure |
Bevacizumab in Combination With Paclitaxel/Carboplatin
Drug Bevacizumab15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
|
IBI305 in Combination With Paclitaxel/Carboplatin
Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
|
|---|---|---|
|
Overall Study
STARTED
|
226
|
224
|
|
Overall Study
COMPLETED
|
220
|
221
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Bevacizumab in Combination With Paclitaxel/Carboplatin
Drug Bevacizumab15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
|
IBI305 in Combination With Paclitaxel/Carboplatin
Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
allergic reaction
|
2
|
1
|
|
Overall Study
non-measurable lesions at baseline
|
1
|
2
|
Baseline Characteristics
Evaluate the Efficacy and Safety of IBI305 in Patients With Advanced or Recurrent Non-squamous NSCLC
Baseline characteristics by cohort
| Measure |
Bevacizumab in Combination With Paclitaxel/Carboplatin
n=220 Participants
Drug Bevacizumab15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
|
IBI305 in Combination With Paclitaxel/Carboplatin
n=221 Participants
Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
|
Total
n=441 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Mean (SD)
|
57.6 years
STANDARD_DEVIATION 8.69 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 9.28 • n=7 Participants
|
57.4 years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
137 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Han
|
217 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
428 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Others
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
220 participants
n=5 Participants
|
221 participants
n=7 Participants
|
441 participants
n=5 Participants
|
|
Height
|
164.93 centimeter
STANDARD_DEVIATION 8.166 • n=5 Participants
|
164.03 centimeter
STANDARD_DEVIATION 7.829 • n=7 Participants
|
164.48 centimeter
STANDARD_DEVIATION 8.003 • n=5 Participants
|
|
Weight
|
62.16 kilogram
STANDARD_DEVIATION 10.844 • n=5 Participants
|
62.14 kilogram
STANDARD_DEVIATION 10.272 • n=7 Participants
|
62.15 kilogram
STANDARD_DEVIATION 10.550 • n=5 Participants
|
PRIMARY outcome
Timeframe: 18 weeksORR（objective response rate）was defined as the percentage of participants in the analysis population who had a Complete Response or a Partial Response per RECIST 1.1. The percentage of participants who experienced a CR or PR is presented. Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Bevacizumab in Combination With Paclitaxel/Carboplatin
n=220 Participants
Drug Bevacizumab 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
|
IBI305 in Combination With Paclitaxel/Carboplatin
n=221 Participants
Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
|
|---|---|---|
|
Objective Response Rate
|
46.4 percentage of participants
|
44.3 percentage of participants
|
SECONDARY outcome
Timeframe: 18.020 monthsOS was defined as the time from randomization to death due to any cause.
Outcome measures
| Measure |
Bevacizumab in Combination With Paclitaxel/Carboplatin
n=220 Participants
Drug Bevacizumab 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
|
IBI305 in Combination With Paclitaxel/Carboplatin
n=221 Participants
Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
|
|---|---|---|
|
Overall Survival Time
|
NA month
insufficient number of participants with events
|
18.020 month
Interval 16.73 to
insufficient number of participants with events
|
SECONDARY outcome
Timeframe: 18 monthsProgression-Free Survival (PFS) Per RECIST 1.1 as Assessed by Independent Radiological Review Committee.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Bevacizumab in Combination With Paclitaxel/Carboplatin
n=220 Participants
Drug Bevacizumab 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
|
IBI305 in Combination With Paclitaxel/Carboplatin
n=221 Participants
Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
|
|---|---|---|
|
Progression-free Survival
|
8.260 months
Interval 6.81 to 8.5
|
8.430 months
Interval 7.17 to 9.59
|
Adverse Events
Bevacizumab in Combination With Paclitaxel/Carboplatin
Serious events: 85 serious events
Other events: 222 other events
Deaths: 5 deaths
IBI305 in Combination With Paclitaxel/Carboplatin
Serious events: 75 serious events
Other events: 216 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Bevacizumab in Combination With Paclitaxel/Carboplatin
n=226 participants at risk
Drug Bevacizumab15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
|
IBI305 in Combination With Paclitaxel/Carboplatin
n=224 participants at risk
Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
|
|---|---|---|
|
Infections and infestations
Lung infection
|
3.1%
7/226 • through study completion, an average of 2 year
|
4.9%
11/224 • through study completion, an average of 2 year
|
|
Infections and infestations
Pneumonia
|
1.3%
3/226 • through study completion, an average of 2 year
|
1.3%
3/224 • through study completion, an average of 2 year
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
3/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
7/226 • through study completion, an average of 2 year
|
1.8%
4/224 • through study completion, an average of 2 year
|
|
Blood and lymphatic system disorders
Anaemia
|
3.5%
8/226 • through study completion, an average of 2 year
|
1.8%
4/224 • through study completion, an average of 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/226 • through study completion, an average of 2 year
|
1.3%
3/224 • through study completion, an average of 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
1.8%
4/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
4/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
General disorders
Fever
|
1.3%
3/226 • through study completion, an average of 2 year
|
0.89%
2/224 • through study completion, an average of 2 year
|
|
Investigations
Platelet count decreased
|
11.9%
27/226 • through study completion, an average of 2 year
|
10.7%
24/224 • through study completion, an average of 2 year
|
|
Investigations
White blood cell count decreased
|
4.4%
10/226 • through study completion, an average of 2 year
|
3.1%
7/224 • through study completion, an average of 2 year
|
|
Investigations
Neutrophil count decreased
|
5.8%
13/226 • through study completion, an average of 2 year
|
2.7%
6/224 • through study completion, an average of 2 year
|
|
Infections and infestations
pulmonary infection
|
3.1%
7/226 • through study completion, an average of 2 year
|
4.9%
11/224 • through study completion, an average of 2 year
|
|
Infections and infestations
Infectious Pneumonia
|
1.3%
3/226 • through study completion, an average of 2 year
|
1.3%
3/224 • through study completion, an average of 2 year
|
|
Infections and infestations
upper respiratory infection
|
1.3%
3/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Infections and infestations
pharyngitis
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Infections and infestations
gastroenteritis
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Infections and infestations
Device associated infection
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Investigations
Fever infection
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Infections and infestations
Herpes zoster
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Infections and infestations
The anus infection
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Infections and infestations
Anal abscess
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Infections and infestations
Phthisis
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Infections and infestations
Sepsis
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Infections and infestations
Gingivitis
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system metastasis
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lymphangitis carcinomatosa
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Blood and lymphatic system disorders
Anemia
|
3.5%
8/226 • through study completion, an average of 2 year
|
1.8%
4/224 • through study completion, an average of 2 year
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.89%
2/224 • through study completion, an average of 2 year
|
|
Immune system disorders
Anaphylaxis occurs almost instantaneously
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Immune system disorders
Hypersensitivity
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Metabolism and nutrition disorders
Hypoproteinemia
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Metabolism and nutrition disorders
Reduced food intake
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Nervous system disorders
Cerebral infarction
|
0.88%
2/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Nervous system disorders
Cerebrovascular disorders
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Nervous system disorders
Neurophlegmon
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Nervous system disorders
Lacunar infarction
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Eye disorders
Angle-closure glaucoma
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Eye disorders
Uveitis
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Eye disorders
Meibomianitis
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Eye disorders
Retinal hemorrhage
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Cardiac disorders
Congestive heart-failure
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.89%
2/224 • through study completion, an average of 2 year
|
|
Cardiac disorders
Ventricular premature contraction
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.89%
2/224 • through study completion, an average of 2 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.89%
2/224 • through study completion, an average of 2 year
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Cardiac disorders
Wolfe-parkinson-white syndrome
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Cardiac disorders
Hydropericardium
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Vascular disorders
Distal embolization
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Vascular disorders
Limb vein thrombosis
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Vascular disorders
Hypertension
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchorrhagia
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.89%
2/224 • through study completion, an average of 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Breathing difficulties
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Expectoration
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.88%
2/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Gastrointestinal disorders
Nausea
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Gastrointestinal disorders
Emesis
|
1.8%
4/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Gastrointestinal disorders
Esophageal obstruction
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Gastrointestinal disorders
Saprodontia
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Hepatobiliary disorders
Hepatic disease
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Musculoskeletal and connective tissue disorders
Gout joint inflammation
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Product Issues
Fever
|
1.3%
3/226 • through study completion, an average of 2 year
|
0.89%
2/224 • through study completion, an average of 2 year
|
|
Product Issues
death
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.89%
2/224 • through study completion, an average of 2 year
|
|
Product Issues
Debilitation
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Investigations
Decreased platelet count
|
11.9%
27/226 • through study completion, an average of 2 year
|
10.7%
24/224 • through study completion, an average of 2 year
|
|
Investigations
Lower white blood cell count
|
4.4%
10/226 • through study completion, an average of 2 year
|
3.1%
7/224 • through study completion, an average of 2 year
|
|
Investigations
Neutrophils count decreased
|
5.8%
13/226 • through study completion, an average of 2 year
|
2.7%
6/224 • through study completion, an average of 2 year
|
|
Investigations
Alanine aminotransferase is elevated
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.89%
2/224 • through study completion, an average of 2 year
|
|
Investigations
Aspartate aminotransferase was elevated
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.89%
2/224 • through study completion, an average of 2 year
|
|
Investigations
Gamma-glutamyl transferase is elevated
|
0.00%
0/226 • through study completion, an average of 2 year
|
0.45%
1/224 • through study completion, an average of 2 year
|
|
Investigations
Haemoglobin reduction
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Investigations
Blood bilirubin is elevated
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Injury, poisoning and procedural complications
Tracheorrhagia
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
|
Injury, poisoning and procedural complications
Fracture
|
0.44%
1/226 • through study completion, an average of 2 year
|
0.00%
0/224 • through study completion, an average of 2 year
|
Other adverse events
| Measure |
Bevacizumab in Combination With Paclitaxel/Carboplatin
n=226 participants at risk
Drug Bevacizumab15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
|
IBI305 in Combination With Paclitaxel/Carboplatin
n=224 participants at risk
Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
9.3%
21/226 • through study completion, an average of 2 year
|
10.3%
23/224 • through study completion, an average of 2 year
|
|
Blood and lymphatic system disorders
Anaemia
|
23.9%
54/226 • through study completion, an average of 2 year
|
23.7%
53/224 • through study completion, an average of 2 year
|
|
Metabolism and nutrition disorders
decreased appetite
|
8.0%
18/226 • through study completion, an average of 2 year
|
8.0%
18/224 • through study completion, an average of 2 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.9%
11/226 • through study completion, an average of 2 year
|
7.6%
17/224 • through study completion, an average of 2 year
|
|
Psychiatric disorders
Sleeplessness
|
6.6%
15/226 • through study completion, an average of 2 year
|
7.1%
16/224 • through study completion, an average of 2 year
|
|
Nervous system disorders
Hypoesthesia
|
10.6%
24/226 • through study completion, an average of 2 year
|
11.2%
25/224 • through study completion, an average of 2 year
|
|
Vascular disorders
Hypertension
|
11.1%
25/226 • through study completion, an average of 2 year
|
11.2%
25/224 • through study completion, an average of 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
16/226 • through study completion, an average of 2 year
|
7.6%
17/224 • through study completion, an average of 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.8%
13/226 • through study completion, an average of 2 year
|
3.1%
7/224 • through study completion, an average of 2 year
|
|
Gastrointestinal disorders
Constipation
|
22.1%
50/226 • through study completion, an average of 2 year
|
19.6%
44/224 • through study completion, an average of 2 year
|
|
Gastrointestinal disorders
Nausea
|
23.0%
52/226 • through study completion, an average of 2 year
|
13.8%
31/224 • through study completion, an average of 2 year
|
|
Gastrointestinal disorders
Vomiting
|
10.6%
24/226 • through study completion, an average of 2 year
|
9.8%
22/224 • through study completion, an average of 2 year
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
30/226 • through study completion, an average of 2 year
|
8.9%
20/224 • through study completion, an average of 2 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.8%
13/226 • through study completion, an average of 2 year
|
1.8%
4/224 • through study completion, an average of 2 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
16/226 • through study completion, an average of 2 year
|
8.0%
18/224 • through study completion, an average of 2 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
14/226 • through study completion, an average of 2 year
|
3.1%
7/224 • through study completion, an average of 2 year
|
|
General disorders
Fever
|
14.6%
33/226 • through study completion, an average of 2 year
|
8.9%
20/224 • through study completion, an average of 2 year
|
|
General disorders
Fatigue
|
5.8%
13/226 • through study completion, an average of 2 year
|
3.6%
8/224 • through study completion, an average of 2 year
|
|
General disorders
Pain
|
6.2%
14/226 • through study completion, an average of 2 year
|
3.6%
8/224 • through study completion, an average of 2 year
|
|
Investigations
White blood cell count decreased
|
79.2%
179/226 • through study completion, an average of 2 year
|
71.9%
161/224 • through study completion, an average of 2 year
|
|
Investigations
Neutrophil count decreased
|
74.8%
169/226 • through study completion, an average of 2 year
|
70.5%
158/224 • through study completion, an average of 2 year
|
|
Investigations
Platelet count decreased
|
43.4%
98/226 • through study completion, an average of 2 year
|
50.4%
113/224 • through study completion, an average of 2 year
|
|
Investigations
AST increased
|
6.2%
14/226 • through study completion, an average of 2 year
|
10.7%
24/224 • through study completion, an average of 2 year
|
|
Investigations
ALT increased
|
7.5%
17/226 • through study completion, an average of 2 year
|
10.3%
23/224 • through study completion, an average of 2 year
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.8%
4/226 • through study completion, an average of 2 year
|
5.8%
13/224 • through study completion, an average of 2 year
|
|
Investigations
Lymphocytes decreased
|
6.6%
15/226 • through study completion, an average of 2 year
|
4.5%
10/224 • through study completion, an average of 2 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place