Trial Outcomes & Findings for A Study Comparing Two Different PROCRIT Doses to a Dose of ARANESP in Anemic Cancer Patients Receiving Chemotherapy (NCT NCT00386152)
NCT ID: NCT00386152
Last Updated: 2013-07-19
Results Overview
Baseline Hb was the Hb value that was consistent with the inclusion criteria and which was obtained within 72 hours of the first dose of study medication
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
235 participants
Primary outcome timeframe
Baseline (Week 1) and Week 7
Results posted on
2013-07-19
Participant Flow
Number of participants randomized:- epoetin alfa (80,000 Units): 77, epoetin alfa (120,000 Units): 80, darbepoetin alfa (500 mcg): 78; Number of participants treated:- epoetin alfa (80,000 Units): 75, epoetin alfa (120,000 Units): 77, darbepoetin alfa (500 mcg): 75.
Participant milestones
| Measure |
Epoetin Alfa (80,000 Units)
epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
|
Epoetin Alfa (120,000 Units)
epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
|
Darbepoetin Alfa (500 Mcg)
darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
77
|
75
|
|
Overall Study
COMPLETED
|
31
|
37
|
42
|
|
Overall Study
NOT COMPLETED
|
44
|
40
|
33
|
Reasons for withdrawal
| Measure |
Epoetin Alfa (80,000 Units)
epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
|
Epoetin Alfa (120,000 Units)
epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
|
Darbepoetin Alfa (500 Mcg)
darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
5
|
4
|
|
Overall Study
Chang from original chemo stratification
|
4
|
5
|
6
|
|
Overall Study
Death
|
3
|
0
|
1
|
|
Overall Study
Disease progression
|
7
|
4
|
5
|
|
Overall Study
Physician Decision
|
13
|
10
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Completed chemotherapy
|
4
|
5
|
1
|
|
Overall Study
Protocol Violation
|
3
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
10
|
Baseline Characteristics
A Study Comparing Two Different PROCRIT Doses to a Dose of ARANESP in Anemic Cancer Patients Receiving Chemotherapy
Baseline characteristics by cohort
| Measure |
Epoetin Alfa (80,000 Units)
n=77 Participants
epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
|
Epoetin Alfa (120,000 Units)
n=80 Participants
epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
|
Darbepoetin Alfa (500 Mcg)
n=78 Participants
darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
41 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Age Continuous
|
65.05 years
STANDARD_DEVIATION 12.54 • n=5 Participants
|
64.84 years
STANDARD_DEVIATION 11.66 • n=7 Participants
|
63.00 years
STANDARD_DEVIATION 12.05 • n=5 Participants
|
64.30 years
STANDARD_DEVIATION 12.07 • n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Chemotherapy Type
Platinum
|
29 participants
n=5 Participants
|
32 participants
n=7 Participants
|
30 participants
n=5 Participants
|
91 participants
n=4 Participants
|
|
Chemotherapy Type
Non-Platinum
|
48 participants
n=5 Participants
|
48 participants
n=7 Participants
|
48 participants
n=5 Participants
|
144 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 1) and Week 7Population: per-protocol (PP) population that includes a subset of the modified intent-to-treat (mITT) population with subjects who were randomized and received at least one dose of study medication, had transfusion-unrelated Hb values obtained at both baseline and Week 7, met inclusion and exclusion criteria, and had no major protocol violations up to Week 7
Baseline Hb was the Hb value that was consistent with the inclusion criteria and which was obtained within 72 hours of the first dose of study medication
Outcome measures
| Measure |
Epoetin Alfa (80,000 Units)
n=57 Participants
epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
|
Epoetin Alfa (120,000 Units)
n=53 Participants
epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
|
Darbepoetin Alfa (500 Mcg)
n=50 Participants
darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
|
|---|---|---|---|
|
Hemoglobin (Hb) Change From Baseline to Study Week 7
|
0.64 g/dL
Standard Deviation 1.30
|
0.40 g/dL
Standard Deviation 1.37
|
0.84 g/dL
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: up to 16 weeksPopulation: modified intention-to-treat (mITT) population that includes the subjects who were randomized, received at least one dose of study medication, and had transfusion-unrelated Hb values obtained at baseline and at least one post baseline visit
Outcome measures
| Measure |
Epoetin Alfa (80,000 Units)
n=71 Participants
epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
|
Epoetin Alfa (120,000 Units)
n=77 Participants
epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
|
Darbepoetin Alfa (500 Mcg)
n=74 Participants
darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
|
|---|---|---|---|
|
Number of Patients Receiving at Least 1 Packed Red Blood Cell (PRBC) Transfusion During Study
|
12 participants
|
22 participants
|
17 participants
|
SECONDARY outcome
Timeframe: up to 16 weeksPopulation: modified intention-to-treat (mITT) population that includes the subjects who were randomized, received at least one dose of study medication, and had transfusion-unrelated Hb values obtained at baseline and at least one post baseline visit
Outcome measures
| Measure |
Epoetin Alfa (80,000 Units)
n=71 Participants
epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
|
Epoetin Alfa (120,000 Units)
n=77 Participants
epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
|
Darbepoetin Alfa (500 Mcg)
n=74 Participants
darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
|
|---|---|---|---|
|
Time to Achieve Hb >= 11 g/dL During Study
|
37 days
Interval 29.0 to 50.0
|
44 days
Interval 29.0 to 85.0
|
36 days
Interval 29.0 to 44.0
|
SECONDARY outcome
Timeframe: up to 16 weeksPopulation: modified intention-to-treat (mITT) population that includes the subjects who were randomized, received at least one dose of study medication, and had transfusion-unrelated Hb values obtained at baseline and at least one post baseline visit
Outcome measures
| Measure |
Epoetin Alfa (80,000 Units)
n=71 Participants
epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
|
Epoetin Alfa (120,000 Units)
n=77 Participants
epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
|
Darbepoetin Alfa (500 Mcg)
n=74 Participants
darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
|
|---|---|---|---|
|
Number of Patients (Hb >= 11 g/dL) During Study.
|
51 participants
|
48 participants
|
56 participants
|
Adverse Events
Epoetin Alfa (80,000 Units)
Serious events: 28 serious events
Other events: 58 other events
Deaths: 0 deaths
Epoetin Alfa (120,000 Units)
Serious events: 23 serious events
Other events: 68 other events
Deaths: 0 deaths
Darbepoetin Alfa (500 Mcg)
Serious events: 25 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epoetin Alfa (80,000 Units)
n=75 participants at risk
epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
|
Epoetin Alfa (120,000 Units)
n=77 participants at risk
epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
|
Darbepoetin Alfa (500 Mcg)
n=75 participants at risk
darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
|
|---|---|---|---|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Vascular disorders
Shock
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Infections and infestations
Staphylococcal sepsis
|
1.3%
1/75
|
0.00%
0/77
|
2.7%
2/75
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/75
|
2.6%
2/77
|
0.00%
0/75
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Investigations
Serum ferritin increased
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
3/75
|
5.2%
4/77
|
1.3%
1/75
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.3%
1/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/75
|
0.00%
0/77
|
2.7%
2/75
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.3%
1/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/75
|
2.6%
2/77
|
0.00%
0/75
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
2.7%
2/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage IV
|
0.00%
0/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Nervous system disorders
Dizziness
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Nervous system disorders
Encephalitis
|
0.00%
0/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Nervous system disorders
Syncope
|
0.00%
0/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Psychiatric disorders
Mental status changes
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Renal and urinary disorders
Haematuria
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/75
|
2.6%
2/77
|
0.00%
0/75
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/75
|
0.00%
0/77
|
2.7%
2/75
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.7%
2/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Vascular disorders
Aortic stenosis
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/75
|
1.3%
1/77
|
1.3%
1/75
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.0%
3/75
|
1.3%
1/77
|
2.7%
2/75
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
1/75
|
0.00%
0/77
|
2.7%
2/75
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
3/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Cardiac disorders
Cardiac failure congestive
|
1.3%
1/75
|
1.3%
1/77
|
1.3%
1/75
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
2/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Gastrointestinal disorders
Ascites
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.7%
2/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/75
|
1.3%
1/77
|
0.00%
0/75
|
|
General disorders
Chest pain
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
General disorders
Systemic inflammatory response syndrome
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Infections and infestations
Bronchitis
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Infections and infestations
Clostridial infection
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Infections and infestations
Enterobacter sepsis
|
1.3%
1/75
|
0.00%
0/77
|
0.00%
0/75
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/75
|
0.00%
0/77
|
1.3%
1/75
|
|
Infections and infestations
Pneumonia
|
5.3%
4/75
|
1.3%
1/77
|
2.7%
2/75
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Infections and infestations
Pneumonia herpes viral
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/75
|
1.3%
1/77
|
0.00%
0/75
|
Other adverse events
| Measure |
Epoetin Alfa (80,000 Units)
n=75 participants at risk
epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
|
Epoetin Alfa (120,000 Units)
n=77 participants at risk
epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
|
Darbepoetin Alfa (500 Mcg)
n=75 participants at risk
darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
3/75
|
5.2%
4/77
|
4.0%
3/75
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.0%
12/75
|
22.1%
17/77
|
18.7%
14/75
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.3%
7/75
|
10.4%
8/77
|
9.3%
7/75
|
|
Gastrointestinal disorders
Abdominal pain
|
9.3%
7/75
|
6.5%
5/77
|
6.7%
5/75
|
|
Gastrointestinal disorders
Constipation
|
9.3%
7/75
|
9.1%
7/77
|
9.3%
7/75
|
|
Gastrointestinal disorders
Diarrhoea
|
17.3%
13/75
|
14.3%
11/77
|
13.3%
10/75
|
|
Gastrointestinal disorders
Nausea
|
14.7%
11/75
|
15.6%
12/77
|
12.0%
9/75
|
|
Gastrointestinal disorders
Vomiting
|
9.3%
7/75
|
11.7%
9/77
|
10.7%
8/75
|
|
General disorders
Asthenia
|
9.3%
7/75
|
5.2%
4/77
|
9.3%
7/75
|
|
General disorders
Fatigue
|
20.0%
15/75
|
19.5%
15/77
|
21.3%
16/75
|
|
General disorders
Oedema peripheral
|
10.7%
8/75
|
7.8%
6/77
|
8.0%
6/75
|
|
General disorders
Pain
|
2.7%
2/75
|
6.5%
5/77
|
2.7%
2/75
|
|
General disorders
Pyrexia
|
10.7%
8/75
|
9.1%
7/77
|
12.0%
9/75
|
|
Infections and infestations
Sinusitis
|
0.00%
0/75
|
5.2%
4/77
|
5.3%
4/75
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/75
|
6.5%
5/77
|
1.3%
1/75
|
|
Infections and infestations
Urinary tract infection
|
2.7%
2/75
|
9.1%
7/77
|
8.0%
6/75
|
|
Investigations
Weight decreased
|
9.3%
7/75
|
5.2%
4/77
|
2.7%
2/75
|
|
Metabolism and nutrition disorders
Anorexia
|
16.0%
12/75
|
7.8%
6/77
|
6.7%
5/75
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.3%
1/75
|
0.00%
0/77
|
5.3%
4/75
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
5/75
|
7.8%
6/77
|
8.0%
6/75
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.0%
3/75
|
7.8%
6/77
|
8.0%
6/75
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
2/75
|
5.2%
4/77
|
5.3%
4/75
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.3%
7/75
|
5.2%
4/77
|
4.0%
3/75
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.7%
2/75
|
5.2%
4/77
|
2.7%
2/75
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
4/75
|
1.3%
1/77
|
6.7%
5/75
|
|
Nervous system disorders
Dizziness
|
9.3%
7/75
|
6.5%
5/77
|
8.0%
6/75
|
|
Nervous system disorders
Dysgeusia
|
1.3%
1/75
|
5.2%
4/77
|
2.7%
2/75
|
|
Nervous system disorders
Headache
|
5.3%
4/75
|
5.2%
4/77
|
5.3%
4/75
|
|
Nervous system disorders
Neuropathy
|
4.0%
3/75
|
9.1%
7/77
|
5.3%
4/75
|
|
Psychiatric disorders
Anxiety
|
4.0%
3/75
|
6.5%
5/77
|
2.7%
2/75
|
|
Psychiatric disorders
Depression
|
4.0%
3/75
|
3.9%
3/77
|
5.3%
4/75
|
|
Psychiatric disorders
Insomnia
|
4.0%
3/75
|
9.1%
7/77
|
9.3%
7/75
|
|
Renal and urinary disorders
Haematuria
|
1.3%
1/75
|
0.00%
0/77
|
8.0%
6/75
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
1/75
|
3.9%
3/77
|
13.3%
10/75
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.0%
6/75
|
9.1%
7/77
|
9.3%
7/75
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
3/75
|
6.5%
5/77
|
2.7%
2/75
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/75
|
5.2%
4/77
|
2.7%
2/75
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
4/75
|
5.2%
4/77
|
9.3%
7/75
|
|
Vascular disorders
Hypotension
|
2.7%
2/75
|
7.8%
6/77
|
5.3%
4/75
|
Additional Information
Nephrology Therapeutic Area, Medical Lead
Centocor Ortho Biotech Services, LLC
Phone: 215-325-4176
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60