Trial Outcomes & Findings for A Trial in Patients With Diffuse Large-B-cell Lymphoma Comparing Pixantrone Against Doxorubicin (NCT NCT00268853)
NCT ID: NCT00268853
Last Updated: 2024-05-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
Subjects followed for 5 years post treatment
Results posted on
2024-05-30
Participant Flow
Participant milestones
| Measure |
CPOP-R
CPOP-R: Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
CHOP-R
CHOP-R: Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
63
|
|
Overall Study
COMPLETED
|
45
|
44
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial in Patients With Diffuse Large-B-cell Lymphoma Comparing Pixantrone Against Doxorubicin
Baseline characteristics by cohort
| Measure |
CPOP-R
n=61 Participants
CPOP-R: Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
CHOP-R
n=63 Participants
CHOP-R: Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
≤ 65 Years
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Customized
>65 Years
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
51 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Subjects followed for 5 years post treatmentPopulation: Intent to Treat Population
Outcome measures
| Measure |
CPOP-R
n=61 Participants
CPOP-R: Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
CHOP-R
n=63 Participants
CHOP-R: Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
|---|---|---|
|
Response Rate
Complete Response
|
24 Participants
|
28 Participants
|
|
Response Rate
Complete Response Unconfirmed
|
20 Participants
|
22 Participants
|
|
Response Rate
Response Rate
|
44 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: The interval between the date of randomization and death due to any cause (up to 100 weeks)Population: Intent to Treat (ITT) Population
Overall Survival time frame is from the interval between the date of randomization and death due to any cause and measures the total number of deaths.
Outcome measures
| Measure |
CPOP-R
n=61 Participants
CPOP-R: Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
CHOP-R
n=63 Participants
CHOP-R: Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
|---|---|---|
|
Overall Survival
|
18 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization to the first documented disease progression or death (up to 100 weeks)Population: Intent to Treat Population
The interval between the date of randomization and the event of disease progression or relapse, institution of a new anticancer treatment or death.
Outcome measures
| Measure |
CPOP-R
n=61 Participants
CPOP-R: Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
CHOP-R
n=63 Participants
CHOP-R: Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
|---|---|---|
|
Median Progression Free Survival (PFS)
|
NA months
Interval 8.6 to
The median survival time is defined to be the time at which the survival curve crosses 50% survival. The curve did not cross 50% (because survival is greater than 50% at the last time point), then median survival is simply non-estimable.The upper CI is non-estimable because there are not sufficient patients contributing events to estimate the upper bound of the confidence interval.
|
17.3 months
Interval 13.3 to
The upper CI is non-estimable because there are not sufficient patients contributing events to estimate the upper bound of the confidence interval.
|
SECONDARY outcome
Timeframe: Subjects followed for 5 years post treatmentPopulation: Intent to Treat Population
Outcome measures
| Measure |
CPOP-R
n=61 Participants
CPOP-R: Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
CHOP-R
n=63 Participants
CHOP-R: Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
|---|---|---|
|
Overall Objective Response Rate
|
50 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: Subjects followed for 5 years post treatmentPopulation: Intent to Treat Population
Outcome measures
| Measure |
CPOP-R
n=61 Participants
CPOP-R: Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
CHOP-R
n=63 Participants
CHOP-R: Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
|---|---|---|
|
Time to Treatment Failure
|
30.3 Months
Interval 7.7 to
The upper CI is not estimable because there are not sufficient patients contributing events to estimate the upper bound of the confidence interval
|
40.1 Months
Interval 15.1 to
The upper CI is not estimable because there are not sufficient patients contributing events to estimate the upper bound of the confidence interval
|
Adverse Events
CPOP-R
Serious events: 28 serious events
Other events: 59 other events
Deaths: 18 deaths
CHOP-R
Serious events: 26 serious events
Other events: 63 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
CPOP-R
n=59 participants at risk
CPOP-R: Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
CHOP-R
n=63 participants at risk
CHOP-R: Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
6.8%
4/59 • Number of events 4
Safety Population
|
3.2%
2/63 • Number of events 2
Safety Population
|
|
Infections and infestations
Sepsis
|
5.1%
3/59 • Number of events 3
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/59
Safety Population
|
3.2%
2/63 • Number of events 2
Safety Population
|
|
Infections and infestations
Urinary Tract Infection
|
1.7%
1/59 • Number of events 1
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Infections and infestations
Bacterial Sepsis
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Infections and infestations
Bronchitis
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Infections and infestations
Cellulitis
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Infections and infestations
Clostridial Infection
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Infections and infestations
Infection
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Infections and infestations
Oesophageal Candidiasis
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Infections and infestations
Psoas Abscess
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Infections and infestations
Thrombophlebitis Septic
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Infections and infestations
Urosepsis
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Infections and infestations
Wound Infection
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncocytoma
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.6%
8/59 • Number of events 8
Safety Population
|
14.3%
9/63 • Number of events 9
Safety Population
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
11.9%
7/59 • Number of events 7
Safety Population
|
12.7%
8/63 • Number of events 8
Safety Population
|
|
Blood and lymphatic system disorders
Anaemia
|
5.1%
3/59 • Number of events 3
Safety Population
|
3.2%
2/63 • Number of events 2
Safety Population
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
2/59 • Number of events 2
Safety Population
|
3.2%
2/63 • Number of events 2
Safety Population
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Psychiatric disorders
Depression
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Nervous system disorders
Dizziness
|
3.4%
2/59 • Number of events 2
Safety Population
|
0.00%
0/63
Safety Population
|
|
Nervous system disorders
Amyotrophic Lateral Sclerosis
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Nervous system disorders
Cerebral Ischemia
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Nervous system disorders
Convulsion
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Nervous system disorders
Presyncope
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Nervous system disorders
Somnolence
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Cardiac disorders
Cardiac Arrest
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.7%
1/59 • Number of events 1
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/59
Safety Population
|
3.2%
2/63 • Number of events 2
Safety Population
|
|
Vascular disorders
Lymphoedema
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Vascular disorders
Thrombophlebitis Superficial
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Vascular disorders
Thrombosis
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Vascular disorders
Vena Cava Thrombosis
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.4%
2/59 • Number of events 2
Safety Population
|
4.8%
3/63 • Number of events 3
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Gastrointestinal disorders
Oesophagitis
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Gastrointestinal disorders
Peritoneal Effusion
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Gastrointestinal disorders
Small Intestinal Perforation
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Renal and urinary disorders
Urinary Bladder Haemorrhage
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Renal and urinary disorders
Urinoma
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Congenital, familial and genetic disorders
Familial Mediterranean Fever
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
General disorders
Pyrexia
|
5.1%
3/59 • Number of events 3
Safety Population
|
7.9%
5/63 • Number of events 5
Safety Population
|
|
General disorders
Asthenia
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
General disorders
Non-cardiac Chest Pain
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Investigations
Ejection Fraction Decreased
|
1.7%
1/59 • Number of events 1
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Investigations
Neutrophil Count Decreased
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Investigations
Platelet Count Decreased
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Investigations
White Blood Cell Count Decreased
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.00%
0/59
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
1.7%
1/59 • Number of events 1
Safety Population
|
0.00%
0/63
Safety Population
|
Other adverse events
| Measure |
CPOP-R
n=59 participants at risk
CPOP-R: Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
CHOP-R
n=63 participants at risk
CHOP-R: Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
|
|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
8.5%
5/59 • Number of events 5
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
Infections and infestations
Bronchitis
|
5.1%
3/59 • Number of events 3
Safety Population
|
4.8%
3/63 • Number of events 3
Safety Population
|
|
Infections and infestations
Candidiasis
|
5.1%
3/59 • Number of events 3
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
4/59 • Number of events 4
Safety Population
|
4.8%
3/63 • Number of events 3
Safety Population
|
|
Infections and infestations
Rhinitis
|
5.1%
3/59 • Number of events 3
Safety Population
|
4.8%
3/63 • Number of events 3
Safety Population
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/59
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.8%
30/59 • Number of events 30
Safety Population
|
52.4%
33/63 • Number of events 33
Safety Population
|
|
Blood and lymphatic system disorders
Anaemia
|
39.0%
23/59 • Number of events 23
Safety Population
|
31.7%
20/63 • Number of events 20
Safety Population
|
|
Blood and lymphatic system disorders
Leukopenia
|
28.8%
17/59 • Number of events 17
Safety Population
|
25.4%
16/63 • Number of events 16
Safety Population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.6%
8/59 • Number of events 8
Safety Population
|
20.6%
13/63 • Number of events 13
Safety Population
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.9%
10/59 • Number of events 10
Safety Population
|
12.7%
8/63 • Number of events 8
Safety Population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.3%
12/59 • Number of events 12
Safety Population
|
15.9%
10/63 • Number of events 10
Safety Population
|
|
Metabolism and nutrition disorders
Anorexia
|
20.3%
12/59 • Number of events 12
Safety Population
|
17.5%
11/63 • Number of events 11
Safety Population
|
|
Metabolism and nutrition disorders
Dehydration
|
13.6%
8/59 • Number of events 8
Safety Population
|
12.7%
8/63 • Number of events 8
Safety Population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.9%
7/59 • Number of events 7
Safety Population
|
9.5%
6/63 • Number of events 6
Safety Population
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
8.5%
5/59 • Number of events 5
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.1%
3/59 • Number of events 3
Safety Population
|
4.8%
3/63 • Number of events 3
Safety Population
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.8%
4/59 • Number of events 4
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.1%
3/59 • Number of events 3
Safety Population
|
3.2%
2/63 • Number of events 2
Safety Population
|
|
Psychiatric disorders
Insomnia
|
10.2%
6/59 • Number of events 6
Safety Population
|
20.6%
13/63 • Number of events 13
Safety Population
|
|
Psychiatric disorders
Anxiety
|
5.1%
3/59 • Number of events 3
Safety Population
|
4.8%
3/63 • Number of events 3
Safety Population
|
|
Psychiatric disorders
Depression
|
5.1%
3/59 • Number of events 3
Safety Population
|
3.2%
2/63 • Number of events 2
Safety Population
|
|
Nervous system disorders
Headache
|
22.0%
13/59 • Number of events 13
Safety Population
|
22.2%
14/63 • Number of events 14
Safety Population
|
|
Nervous system disorders
Paraesthesia
|
15.3%
9/59 • Number of events 9
Safety Population
|
19.0%
12/63 • Number of events 12
Safety Population
|
|
Nervous system disorders
Neuropathy Peripheral
|
22.0%
13/59 • Number of events 13
Safety Population
|
9.5%
6/63 • Number of events 6
Safety Population
|
|
Nervous system disorders
Dizziness
|
13.6%
8/59 • Number of events 8
Safety Population
|
12.7%
8/63 • Number of events 8
Safety Population
|
|
Nervous system disorders
Dysgeusia
|
10.2%
6/59 • Number of events 6
Safety Population
|
11.1%
7/63 • Number of events 7
Safety Population
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
10.2%
6/59 • Number of events 6
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
Nervous system disorders
Hypoaesthesia
|
10.2%
6/59 • Number of events 6
Safety Population
|
4.8%
3/63 • Number of events 3
Safety Population
|
|
Nervous system disorders
Hyporeflexia
|
8.5%
5/59 • Number of events 5
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
Nervous system disorders
Polyneuropathy
|
8.5%
5/59 • Number of events 5
Safety Population
|
4.8%
3/63 • Number of events 3
Safety Population
|
|
Eye disorders
Conjunctivitis
|
5.1%
3/59 • Number of events 3
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Vascular disorders
Hypertension
|
5.1%
3/59 • Number of events 3
Safety Population
|
7.9%
5/63 • Number of events 5
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
8/59 • Number of events 8
Safety Population
|
22.2%
14/63 • Number of events 14
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.5%
5/59 • Number of events 5
Safety Population
|
14.3%
9/63 • Number of events 9
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.8%
4/59 • Number of events 4
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/59
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.5%
5/59 • Number of events 5
Safety Population
|
0.00%
0/63
Safety Population
|
|
Gastrointestinal disorders
Nausea
|
40.7%
24/59 • Number of events 24
Safety Population
|
36.5%
23/63 • Number of events 23
Safety Population
|
|
Gastrointestinal disorders
Constipation
|
30.5%
18/59 • Number of events 18
Safety Population
|
31.7%
20/63 • Number of events 20
Safety Population
|
|
Gastrointestinal disorders
Vomiting
|
16.9%
10/59 • Number of events 10
Safety Population
|
23.8%
15/63 • Number of events 15
Safety Population
|
|
Gastrointestinal disorders
Diarrhoea
|
16.9%
10/59 • Number of events 10
Safety Population
|
19.0%
12/63 • Number of events 12
Safety Population
|
|
Gastrointestinal disorders
Abdominal Pain
|
13.6%
8/59 • Number of events 8
Safety Population
|
11.1%
7/63 • Number of events 7
Safety Population
|
|
Gastrointestinal disorders
Dyspepsia
|
11.9%
7/59 • Number of events 7
Safety Population
|
12.7%
8/63 • Number of events 8
Safety Population
|
|
Gastrointestinal disorders
Stomatitis
|
6.8%
4/59 • Number of events 4
Safety Population
|
17.5%
11/63 • Number of events 11
Safety Population
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.8%
4/59 • Number of events 4
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
Gastrointestinal disorders
Dysphagia
|
5.1%
3/59 • Number of events 3
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
2/59 • Number of events 2
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
18.6%
11/59 • Number of events 11
Safety Population
|
11.1%
7/63 • Number of events 7
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.9%
10/59 • Number of events 10
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
44.1%
26/59 • Number of events 26
Safety Population
|
39.7%
25/63 • Number of events 25
Safety Population
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
23.7%
14/59 • Number of events 14
Safety Population
|
0.00%
0/63
Safety Population
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
5.1%
3/59 • Number of events 3
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
3/59 • Number of events 3
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
5.1%
3/59 • Number of events 3
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.6%
8/59 • Number of events 8
Safety Population
|
9.5%
6/63 • Number of events 6
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
10.2%
6/59 • Number of events 6
Safety Population
|
9.5%
6/63 • Number of events 6
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
8.5%
5/59 • Number of events 5
Safety Population
|
7.9%
5/63 • Number of events 5
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
6.8%
4/59 • Number of events 4
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.8%
4/59 • Number of events 4
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
5.1%
3/59 • Number of events 3
Safety Population
|
1.6%
1/63 • Number of events 1
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.1%
3/59 • Number of events 3
Safety Population
|
0.00%
0/63
Safety Population
|
|
Renal and urinary disorders
Pollakiuria
|
1.7%
1/59 • Number of events 1
Safety Population
|
12.7%
8/63 • Number of events 8
Safety Population
|
|
Renal and urinary disorders
Chromaturia
|
11.9%
7/59 • Number of events 7
Safety Population
|
0.00%
0/63
Safety Population
|
|
General disorders
Pyrexia
|
18.6%
11/59 • Number of events 11
Safety Population
|
19.0%
12/63 • Number of events 12
Safety Population
|
|
General disorders
Asthenia
|
30.5%
18/59 • Number of events 18
Safety Population
|
25.4%
16/63 • Number of events 16
Safety Population
|
|
General disorders
Mucosal Inflammation
|
5.1%
3/59 • Number of events 3
Safety Population
|
9.5%
6/63 • Number of events 6
Safety Population
|
|
General disorders
Fatigue
|
44.1%
26/59 • Number of events 26
Safety Population
|
39.7%
25/63 • Number of events 25
Safety Population
|
|
General disorders
Oedema Peripheral
|
20.3%
12/59 • Number of events 12
Safety Population
|
19.0%
12/63 • Number of events 12
Safety Population
|
|
General disorders
Chest Pain
|
3.4%
2/59 • Number of events 2
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
General disorders
Chills
|
3.4%
2/59 • Number of events 2
Safety Population
|
6.3%
4/63 • Number of events 4
Safety Population
|
|
General disorders
Influenza-like Illness
|
5.1%
3/59 • Number of events 3
Safety Population
|
4.8%
3/63 • Number of events 3
Safety Population
|
|
Investigations
Ejection Fraction Decreased
|
30.5%
18/59 • Number of events 18
Safety Population
|
30.2%
19/63 • Number of events 19
Safety Population
|
|
Investigations
Weight Decreased
|
18.6%
11/59 • Number of events 11
Safety Population
|
11.1%
7/63 • Number of events 7
Safety Population
|
|
Investigations
Alanine Aminotransferase Increased
|
5.1%
3/59 • Number of events 3
Safety Population
|
3.2%
2/63 • Number of events 2
Safety Population
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.1%
3/59 • Number of events 3
Safety Population
|
3.2%
2/63 • Number of events 2
Safety Population
|
Additional Information
Anton Egorov, Associate Project Director Clinical Development
Institut de Recherches Internationales Servier
Phone: +33 1 55 72 31 94
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place