Trial Outcomes & Findings for Mitoxantrone ± Cetuximab 2nd Line Androgen Independent Prostate Cancer (AIPC) (NCT NCT00661492)
NCT ID: NCT00661492
Last Updated: 2016-12-09
Results Overview
TTP will be measured from the start of treatment date to the date the patient is first recorded as having disease progression (even in patients who discontinue study treatment early due to toxicity or death due to disease progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
115 participants
Primary outcome timeframe
24 months
Results posted on
2016-12-09
Participant Flow
Between May 2008 and March 2009, 115 eligible patients were enrolled, 75 in the CMP arm and 40 in the MP arm.
5 patients with Withdrew Consent and 23 patients with Failed Entry.
Participant milestones
| Measure |
Arm 1
Novantrone+Erbitux
|
Arm 2
Novantrone
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
40
|
|
Overall Study
COMPLETED
|
7
|
11
|
|
Overall Study
NOT COMPLETED
|
68
|
29
|
Reasons for withdrawal
| Measure |
Arm 1
Novantrone+Erbitux
|
Arm 2
Novantrone
|
|---|---|---|
|
Overall Study
Adverse Event
|
16
|
13
|
|
Overall Study
Disease Progression
|
44
|
14
|
|
Overall Study
Patient Request
|
6
|
1
|
|
Overall Study
Investigator Request
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Mitoxantrone ± Cetuximab 2nd Line Androgen Independent Prostate Cancer (AIPC)
Baseline characteristics by cohort
| Measure |
Arm 1
n=75 Participants
Novantrone+Erbitux
|
Arm 2
n=40 Participants
Novantrone
|
Total
n=115 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
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
58 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Age, Continuous
|
71.5 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
70.7 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
71.2 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
65 participants
n=5 Participants
|
32 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
40 participants
n=7 Participants
|
115 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: ITT population
TTP will be measured from the start of treatment date to the date the patient is first recorded as having disease progression (even in patients who discontinue study treatment early due to toxicity or death due to disease progression.
Outcome measures
| Measure |
Arm 1
n=75 Participants
Novantrone+Erbitux
|
Arm 2
n=40 Participants
Novantrone
|
|---|---|---|
|
Median Time to Progression (TTP)
|
4.9 Months
Interval 0.5 to 20.5
|
6.6 Months
Interval 0.3 to 23.1
|
SECONDARY outcome
Timeframe: 24 months.Population: Patients who received bone scans or had bone progression only (bone pain/pathologic fracture/palliative radiation).
Radiographic progression: 1\) For bone scan, 2 unequivocal new lesions confirmed by a subsequent bone scan with at least 1 more new lesion; 2) Skeletal related event (eg, fracture, need for radiation to bone for pain, spinal cord compression, need for surgery to bone to prevent or treat a pathologic fracture).
Outcome measures
| Measure |
Arm 1
n=50 Participants
Novantrone+Erbitux
|
Arm 2
n=24 Participants
Novantrone
|
|---|---|---|
|
2-year Radiographically Evident Progression-free Survival (REPFS).
|
0.73 Probability of REPFS at 2-year
Interval 0.56 to 0.85
|
0.80 Probability of REPFS at 2-year
Interval 0.55 to 0.92
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Patients with solid tumors
ORR = CR + PR Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Arm 1
n=45 Participants
Novantrone+Erbitux
|
Arm 2
n=26 Participants
Novantrone
|
|---|---|---|
|
Objective Response Rate (ORR)
|
2.2 percentage of participants
Interval 0.1 to 11.8
|
3.8 percentage of participants
Interval 0.1 to 19.6
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Patients with Prostate-specific antigen (PSA) Information
Defined as the time from initiation of therapy until the first 25% increase from baseline in non-responders or 50% increase from nadir in responders as defined above. A minimum increase in the PSA of 5 ng/mL will be required for progression.
Outcome measures
| Measure |
Arm 1
n=65 Participants
Novantrone+Erbitux
|
Arm 2
n=34 Participants
Novantrone
|
|---|---|---|
|
Median Time to Prostate-specific Antigen (PSA) Progression
|
2.7 Months
Interval 0.03 to 24.1
|
2.7 Months
Interval 0.03 to 22.3
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Evaluable Population with Prostate-specific antigen (PSA) Information
Defined as the fraction of patients with a ≥50% reduction in serum PSA confirmed by a second serum PSA at least 3 weeks later
Outcome measures
| Measure |
Arm 1
n=65 Participants
Novantrone+Erbitux
|
Arm 2
n=34 Participants
Novantrone
|
|---|---|---|
|
Prostate-specific Antigen (PSA) Response Rate
|
7.7 percentage of participants
Interval 2.5 to 17.0
|
17.6 percentage of participants
Interval 6.8 to 34.5
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Evaluable Population with Prostate-specific antigen (PSA) Information
PSA doubling time = \[log (2)× t\] ÷ \[log (final PSA) - log (initial PSA)\]
Outcome measures
| Measure |
Arm 1
n=65 Participants
Novantrone+Erbitux
|
Arm 2
n=34 Participants
Novantrone
|
|---|---|---|
|
Prostate-specific Antigen (PSA) Doubling Time
|
2.3 months
Interval -61.3 to 62.8
|
1.5 months
Interval -2544.0 to 76.4
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: ITT population
PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Outcome measures
| Measure |
Arm 1
n=75 Participants
Novantrone+Erbitux
|
Arm 2
n=40 Participants
Novantrone
|
|---|---|---|
|
Median Progression-free Survival (PFS)
|
4.2 months
Interval 0.5 to 20.5
|
5.5 months
Interval 0.3 to 23.1
|
SECONDARY outcome
Timeframe: 30 monthsPopulation: ITT population
OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Outcome measures
| Measure |
Arm 1
n=75 Participants
Novantrone+Erbitux
|
Arm 2
n=40 Participants
Novantrone
|
|---|---|---|
|
Median Overall Survival (OS)
|
11.9 months
Interval 0.5 to 24.1
|
15.7 months
Interval 0.9 to 29.4
|
Adverse Events
Arm 1
Serious events: 39 serious events
Other events: 74 other events
Deaths: 0 deaths
Arm 2
Serious events: 12 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=75 participants at risk
Novantrone+Erbitux
|
Arm 2
n=39 participants at risk
Novantrone
|
|---|---|---|
|
Vascular disorders
ACCIDENT CEREBROVASCULAR
|
0.00%
0/75 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Immune system disorders
ALLERGIC REACTION
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
ANEMIA
|
5.3%
4/75 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
ANOREXIA
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
BELL'S PALSY
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Vascular disorders
CARDIAC ARREST
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Infections and infestations
CELLULITIS
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
General disorders
CHEST PAIN
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
General disorders
CHILLS
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
CONFUSION
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Vascular disorders
CONGESTIVE HEART FAILURE
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
DEHYDRATION
|
4.0%
3/75 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
DIARRHEA
|
0.00%
0/75 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
DISTRESS RESPIRATORY
|
0.00%
0/75 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
DIZZINESS
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
EDEMA
|
0.00%
0/75 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
EFFUSION PLEURAL
|
2.7%
2/75 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
EMBOLISM PULMONARY
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
EMBOLUS PULMONARY
|
0.00%
0/75 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Infections and infestations
FEVER
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN METASTASES
|
0.00%
0/75 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Investigations
DEATH SUDDEN (NOS)
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Investigations
DISEASE PROGRESSION
|
5.3%
4/75 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Cardiac disorders
FIBRILLATION ATRIAL
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Cardiac disorders
FLUTTER ATRIAL
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
FRACTURE PATHOLOGICAL
|
2.7%
2/75 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
GASTROINTESTINAL BLEEDING
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
GI HEMORRHAGE
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Renal and urinary disorders
HEMATURIA
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Vascular disorders
HYPOTENSION
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Infections and infestations
INFECTION BACTERIAL
|
5.3%
4/75 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Infections and infestations
INFECTION BLADDER
|
4.0%
3/75 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Infections and infestations
INFECTION VIRAL
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Cardiac disorders
ISCHEMIA MYOCARDIAL
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
MENTAL DEFICIENCY
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
MENTAL DETERIORATION
|
0.00%
0/75 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Psychiatric disorders
MOOD ALTERED
|
0.00%
0/75 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
General disorders
MULTIPLE ORGAN FAILURE
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS
|
2.7%
2/75 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/75 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
NAUSEA
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
2.7%
2/75 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
NOSEBLEED
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
General disorders
PAIN
|
2.7%
2/75 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
PAIN BACK
|
2.7%
2/75 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
PAIN PELVIC
|
1.3%
1/75 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
PAIN SACROILIAC
|
0.00%
0/75 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Vascular disorders
PHLEBITIS
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
2.7%
2/75 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Endocrine disorders
PROSTATIC DISORDER
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
RECTAL BLEEDING
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
RECTAL DISORDER
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
RECTAL PAIN
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
RENAL FAILURE
|
4.0%
3/75 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/75 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
SPINAL CORD COMPRESSION
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Vascular disorders
STROKE
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
SYNCOPE
|
1.3%
1/75 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Cardiac disorders
TACHYCARDIA
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Vascular disorders
THROMBOSIS
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
TRACHEOBRONCHITIS
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Renal and urinary disorders
URINARY BLADDER OBSTRUCTION
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/75 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
VOMITING
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
General disorders
WEAKNESS
|
4.0%
3/75 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
Other adverse events
| Measure |
Arm 1
n=75 participants at risk
Novantrone+Erbitux
|
Arm 2
n=39 participants at risk
Novantrone
|
|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
64.0%
48/75 • Number of events 139 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
35.9%
14/39 • Number of events 35 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
General disorders
FATIGUE
|
48.0%
36/75 • Number of events 50 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
56.4%
22/39 • Number of events 34 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
LEUCOPENIA
|
36.0%
27/75 • Number of events 141 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
25.6%
10/39 • Number of events 23 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Skin and subcutaneous tissue disorders
RASH
|
33.3%
25/75 • Number of events 63 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
7.7%
3/39 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
ANEMIA
|
32.0%
24/75 • Number of events 50 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
38.5%
15/39 • Number of events 41 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
General disorders
PAIN
|
32.0%
24/75 • Number of events 35 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
30.8%
12/39 • Number of events 17 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
30.7%
23/75 • Number of events 58 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
10.3%
4/39 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
NAUSEA
|
22.7%
17/75 • Number of events 29 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
28.2%
11/39 • Number of events 13 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
ANOREXIA
|
22.7%
17/75 • Number of events 19 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
25.6%
10/39 • Number of events 11 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
22.7%
17/75 • Number of events 56 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
20.5%
8/39 • Number of events 14 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
22.7%
17/75 • Number of events 26 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
10.3%
4/39 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
CONSTIPATION
|
21.3%
16/75 • Number of events 20 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
23.1%
9/39 • Number of events 9 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
DIARRHEA
|
18.7%
14/75 • Number of events 22 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
23.1%
9/39 • Number of events 10 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
EDEMA
|
17.3%
13/75 • Number of events 15 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
17.9%
7/39 • Number of events 8 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
VOMITING
|
16.0%
12/75 • Number of events 19 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
23.1%
9/39 • Number of events 10 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
DIZZINESS
|
16.0%
12/75 • Number of events 18 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
17.9%
7/39 • Number of events 9 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
14.7%
11/75 • Number of events 19 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
15.4%
6/39 • Number of events 9 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
14.7%
11/75 • Number of events 13 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
10.3%
4/39 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
13.3%
10/75 • Number of events 13 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
10.3%
4/39 • Number of events 5 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Infections and infestations
INFECTION BACTERIAL
|
13.3%
10/75 • Number of events 13 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
PAIN BACK
|
12.0%
9/75 • Number of events 13 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
15.4%
6/39 • Number of events 8 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
MUCOSITIS
|
12.0%
9/75 • Number of events 14 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
10.3%
4/39 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
General disorders
WEAKNESS
|
12.0%
9/75 • Number of events 10 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
7.7%
3/39 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Infections and infestations
FEVER
|
12.0%
9/75 • Number of events 10 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX
|
9.3%
7/75 • Number of events 11 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
10.3%
4/39 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Immune system disorders
ALLERGIC REACTION
|
9.3%
7/75 • Number of events 8 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
8.0%
6/75 • Number of events 15 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
23.1%
9/39 • Number of events 19 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
INFECTION UPPER RESPIRATORY
|
8.0%
6/75 • Number of events 6 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
INSOMNIA
|
8.0%
6/75 • Number of events 6 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
8.0%
6/75 • Number of events 9 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
General disorders
WEIGHT LOSS
|
8.0%
6/75 • Number of events 6 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
HEADACHE
|
6.7%
5/75 • Number of events 5 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
12.8%
5/39 • Number of events 5 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
DEHYDRATION
|
6.7%
5/75 • Number of events 9 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
10.3%
4/39 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
NEUROPATHY
|
6.7%
5/75 • Number of events 5 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
7.7%
3/39 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Renal and urinary disorders
HEMATURIA
|
6.7%
5/75 • Number of events 6 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
6.7%
5/75 • Number of events 6 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
General disorders
CHILLS
|
6.7%
5/75 • Number of events 5 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Eye disorders
CONJUNCTIVITIS
|
6.7%
5/75 • Number of events 6 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Infections and infestations
INFECTION FUNGAL
|
6.7%
5/75 • Number of events 9 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
6.7%
5/75 • Number of events 37 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
General disorders
MUSCLE WEAKNESS
|
6.7%
5/75 • Number of events 9 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
6.7%
5/75 • Number of events 5 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
4.0%
3/75 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
12.8%
5/39 • Number of events 5 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Metabolism and nutrition disorders
ALKALINE PHOSPHASTASE SERUM INCREASE
|
5.3%
4/75 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
10.3%
4/39 • Number of events 8 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
5.3%
4/75 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
10.3%
4/39 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Infections and infestations
INFECTION BLADDER
|
5.3%
4/75 • Number of events 6 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
7.7%
3/39 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Infections and infestations
CELLULITIS
|
5.3%
4/75 • Number of events 7 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Renal and urinary disorders
URINARY URGENCY/FREQUENCY
|
5.3%
4/75 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
2.6%
1/39 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Psychiatric disorders
ANXIETY
|
5.3%
4/75 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
General disorders
CHEST PAIN
|
5.3%
4/75 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Eye disorders
EPIPHORA
|
5.3%
4/75 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Metabolism and nutrition disorders
GLUCOSE BLOOD INCREASED
|
5.3%
4/75 • Number of events 8 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGITIS
|
5.3%
4/75 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
0.00%
0/39 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
4.0%
3/75 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
7.7%
3/39 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Metabolism and nutrition disorders
ALT INCREASED
|
4.0%
3/75 • Number of events 5 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 6 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Metabolism and nutrition disorders
AST INCREASED
|
4.0%
3/75 • Number of events 7 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Metabolism and nutrition disorders
CREATININE SERUM INCREASED
|
4.0%
3/75 • Number of events 9 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
SHOULDER PAIN
|
2.7%
2/75 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
7.7%
3/39 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Vascular disorders
HYPOTENSION
|
2.7%
2/75 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Vascular disorders
THROMBOSIS
|
2.7%
2/75 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Cardiac disorders
CARDIAC INSUFFICIENCY
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
10.3%
4/39 • Number of events 4 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
DYSGUESIA
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
7.7%
3/39 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
DRY MOUTH
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
RECTAL BLEEDING
|
1.3%
1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 3 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
BRUISE
|
0.00%
0/75 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/75 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
5.1%
2/39 • Number of events 2 • During the whole treatment period, up to 30 days following last dose
For treated patients only, assessed at each treatment visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place