Trial Outcomes & Findings for Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma (NCT NCT00884286)
NCT ID: NCT00884286
Last Updated: 2018-04-25
Results Overview
The primary objective of the study was the exploration of the efficacy of plitidepsin when given as a weekly 1-hour infusion on Days 1, 8 and 15 in 4-week cycles to patients with relapsed or refractory aggressive non-Hodgkin's Lymphoma. The primary efficacy endpoint was the Objective Response Rate, defined as the combined rate of Complete Response (CR), Unconfirmed Complete Response (CRu) and Partial Response (PR) following the definition of response according to the International Working Group (IWG) criteria for Non-Hodgkin's Lymphoma (NHL).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first
Results posted on
2018-04-25
Participant Flow
Participant milestones
| Measure |
Aplidin® (Cohort Non-cutaneous PTCL)
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
Aplidin®(Other Lymphoma)
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
32
|
33
|
Reasons for withdrawal
| Measure |
Aplidin® (Cohort Non-cutaneous PTCL)
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
Aplidin®(Other Lymphoma)
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
|---|---|---|
|
Overall Study
Progressive disease
|
21
|
28
|
|
Overall Study
Toxicity
|
4
|
1
|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Septic shock
|
1
|
0
|
|
Overall Study
Thrombus in right auricle
|
1
|
0
|
|
Overall Study
Not treated
|
2
|
1
|
|
Overall Study
Comprised lung carcinoma
|
0
|
1
|
Baseline Characteristics
Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Aplidin® (Cohort Non-cutaneous)
n=34 Participants
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
Aplidin® (Cohort Other Lymphoma)
n=33 Participants
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
17 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
Between 18 and 49 years
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Customized
Between 50 and 69 years
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Customized
>= 70 years
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Peru
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured firstPopulation: The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous Peripheral T-cell Lymphoma (PTCL), and for the subset of treated patients with other lymphomas.
The primary objective of the study was the exploration of the efficacy of plitidepsin when given as a weekly 1-hour infusion on Days 1, 8 and 15 in 4-week cycles to patients with relapsed or refractory aggressive non-Hodgkin's Lymphoma. The primary efficacy endpoint was the Objective Response Rate, defined as the combined rate of Complete Response (CR), Unconfirmed Complete Response (CRu) and Partial Response (PR) following the definition of response according to the International Working Group (IWG) criteria for Non-Hodgkin's Lymphoma (NHL).
Outcome measures
| Measure |
Arm One
n=67 Participants
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
Arm One (Subset of Treated Patients With Other Lymphomas)
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
|---|---|---|
|
Objective Response Rate
Non-cutaneous PTCL · Complete response
|
2 Participants
|
—
|
|
Objective Response Rate
Non-cutaneous PTCL · Partial response
|
4 Participants
|
—
|
|
Objective Response Rate
Non-cutaneous PTCL · Stable Disease
|
6 Participants
|
—
|
|
Objective Response Rate
Non-cutaneous PTCL · Progressive disease
|
17 Participants
|
—
|
|
Objective Response Rate
Non-cutaneous PTCL · Not evaluable
|
5 Participants
|
—
|
|
Objective Response Rate
Other lymphomas · Complete response
|
0 Participants
|
—
|
|
Objective Response Rate
Other lymphomas · Partial response
|
0 Participants
|
—
|
|
Objective Response Rate
Other lymphomas · Stable Disease
|
6 Participants
|
—
|
|
Objective Response Rate
Other lymphomas · Progressive disease
|
24 Participants
|
—
|
|
Objective Response Rate
Other lymphomas · Not evaluable
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured firstPopulation: The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas. Six responders belong to the Non-cutaneous PTCL cohort
Time to response onset was defined as the time from the first day of plitidepsin treatment to the first documentation of response.
Outcome measures
| Measure |
Arm One
n=6 Participants
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
Arm One (Subset of Treated Patients With Other Lymphomas)
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
|---|---|---|
|
Time to Response Onset
|
7.5 weeks
Interval 6.9 to 7.9
|
—
|
SECONDARY outcome
Timeframe: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured firstPopulation: The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas. The six responders belong to the Non-cutaneous PTCL cohort.
Duration of response was defined as the time from the first documented objective response (CR, CRu or PR) to disease progression or death. Patients who had not progressed or died were to have their duration censored at the date of their last disease assessment.
Outcome measures
| Measure |
Arm One
n=6 Participants
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
Arm One (Subset of Treated Patients With Other Lymphomas)
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
|---|---|---|
|
Duration of Response
|
2.2 months
Interval 0.0 to 27.9
|
—
|
SECONDARY outcome
Timeframe: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured firstPopulation: The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.
Time to progression (TTP) was to be calculated from the first day of plitidepsin treatment to the date of disease progression.
Outcome measures
| Measure |
Arm One
n=59 Participants
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
Arm One (Subset of Treated Patients With Other Lymphomas)
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
|---|---|---|
|
Time to Progression
Non-cutaneous PTCL
|
1.6 months
Interval 1.1 to 3.0
|
—
|
|
Time to Progression
Other lymphomas
|
1.3 months
Interval 0.8 to 1.6
|
—
|
SECONDARY outcome
Timeframe: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured firstPopulation: The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.
Time to subsequent therapy was to be calculated from the first infusion of the study drug to the start date of the subsequent therapy. Patients without subsequent therapy were to be censored at their last reported date.
Outcome measures
| Measure |
Arm One
n=32 Participants
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
Arm One (Subset of Treated Patients With Other Lymphomas)
n=32 Participants
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
|---|---|---|
|
Time to Subsequent Chemotherapy
|
3.8 months
Interval 2.3 to 5.6
|
1.9 months
Interval 1.4 to 2.6
|
SECONDARY outcome
Timeframe: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured firstPopulation: The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.
Progression-free survival (PFS) was to be calculated from the date of registration to the date of first objective disease progression or death from any cause. Patients who were lost to follow-up without documentation of progression were to be censored at the last date they were assessed and found progression-free. A patient receiving a new treatment in the absence of documented progression was to be considered as progressing at the time of re-treatment.
Outcome measures
| Measure |
Arm One
n=59 Participants
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
Arm One (Subset of Treated Patients With Other Lymphomas)
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
|---|---|---|
|
Progression-free Survival
Non-cutaneous PTCL
|
1.6 months
Interval 1.1 to 2.7
|
—
|
|
Progression-free Survival
Other lymphomas
|
1.3 months
Interval 0.8 to 1.6
|
—
|
SECONDARY outcome
Timeframe: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured firstPopulation: The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.
Overall survival (OS) was to be calculated from the date of registration to the date of death from any cause. Patients with no documented death were to be censored at the last date they were known to be alive.
Outcome measures
| Measure |
Arm One
n=59 Participants
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
Arm One (Subset of Treated Patients With Other Lymphomas)
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
|---|---|---|
|
Overall Survival
Non-cutaneous PTCL
|
10.2 months
Interval 4.4 to 24.3
|
—
|
|
Overall Survival
Other lymphomas
|
4.5 months
Interval 2.7 to 6.4
|
—
|
Adverse Events
Aplidin® (Cohort Non-cutaneous PTCL)
Serious events: 13 serious events
Other events: 31 other events
Deaths: 10 deaths
Aplidin® (Cohort Other Lymphomas)
Serious events: 11 serious events
Other events: 32 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Aplidin® (Cohort Non-cutaneous PTCL)
n=32 participants at risk
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
Aplidin® (Cohort Other Lymphomas)
n=32 participants at risk
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Diarrhea NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Cardiac disorders
Atrial thrombosis
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Fatigue
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Condition aggravated
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Pyrexia
|
9.4%
3/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
9.4%
3/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Rigors
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Disease progression NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Injection site reaction NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Investigations
Cardiac troponin I increased
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Investigations
Ejection fraction decreased
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Investigations
Alanine aminotransferase increased
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Blood and lymphatic system disorders
Anemia NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness NOS
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Nervous system disorders
Guillain-Barré syndrome
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Nervous system disorders
Syncope
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Dysponea NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Vascular disorders
Hypotension NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Enteritis necroticans
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Gastroenteritis NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Pneumonia NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Septic shock
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
Other adverse events
| Measure |
Aplidin® (Cohort Non-cutaneous PTCL)
n=32 participants at risk
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
Aplidin® (Cohort Other Lymphomas)
n=32 participants at risk
Aplidin® given as a 1-hour weekly IV infusion
Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin lesion NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
15.6%
5/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Blood and lymphatic system disorders
Anaemia NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Cardiac disorders
Arrhythmia NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Cardiac disorders
Bradycardia NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Cardiac disorders
Cardiac flutter
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Cardiac disorders
Sinus bradycardia
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Cardiac disorders
Supraventricular arrhythmia NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Cardiac disorders
Tachycardia NOS
|
12.5%
4/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Cardiac disorders
Ventricular arrhythmia NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Cardiac disorders
Ventricular hypokinesia
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Endocrine disorders
Acquired hypothyroidism
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Endocrine disorders
Cushingoid
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Eye disorders
Eye inflammation NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Eye disorders
Eye pain
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Eye disorders
Eyelid oedema
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Eye disorders
Ophthalmoplegia NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Eye disorders
Uveitis NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Eye disorders
Vision blurred
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Eye disorders
Visual disturbance NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
18.8%
6/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
12.5%
4/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
9.4%
3/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Aptyalism
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Ascites
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
18.8%
6/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
31.2%
10/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
21.9%
7/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Enteritis
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Glossodynia
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Intestinal obstruction NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Nausea
|
34.4%
11/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
40.6%
13/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Vomiting NOS
|
15.6%
5/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
15.6%
5/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Chest pain
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Condition aggravated
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Fatigue
|
62.5%
20/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
59.4%
19/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
General physical health deterioration
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Inflammation NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Inflammation localised
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Oedema NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Oedema peripheral
|
15.6%
5/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
40.6%
13/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Pain NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Pyrexia
|
50.0%
16/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
12.5%
4/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
General disorders
Rigors
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Hepatobiliary disorders
Cholestasis
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Hepatobiliary disorders
Hepatomegaly
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Abscess NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Bacterial infection NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Candidal infection NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Clostridial infection NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Cytomegalovirus infection
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Eye infection NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Fungal infection NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Infection NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Infectious mononucleosis
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Influenza
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Pneumocystis carinii infection
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Pseudomonas infection NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Sinusitis NOS
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Staphylococcal sepsis
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Infections and infestations
Tonsillitis NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
9.4%
3/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Investigations
Blood alkaline phosphatase NOS increased
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Investigations
Blood creatine phosphokinase increased
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Investigations
Blood urine present
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Investigations
Neutrophil count decreased
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Investigations
Platelet count decreased
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Investigations
Transaminases increased
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Investigations
Weight decreased
|
21.9%
7/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
9.4%
3/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Investigations
Weight increased
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Metabolism and nutrition disorders
Anorexia
|
28.1%
9/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
15.6%
5/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Metabolism and nutrition disorders
Hypoglycaemia NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
4/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
12.5%
4/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
9.4%
3/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
12.5%
4/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness NOS
|
9.4%
3/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
9.4%
3/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.4%
3/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
34.4%
11/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Musculoskeletal and connective tissue disorders
Myopathy toxic
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Musculoskeletal and connective tissue disorders
Pain in limb
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
12.5%
4/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
28.1%
9/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Nervous system disorders
Aphonia
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Nervous system disorders
Dysphonia
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Nervous system disorders
Headache NOS
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Nervous system disorders
Hyperaesthesia
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Nervous system disorders
Hyporeflexia
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Nervous system disorders
Paraesthesia
|
9.4%
3/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
12.5%
4/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Nervous system disorders
Peripheral neuropathy NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Nervous system disorders
Syncope
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Nervous system disorders
Tremor
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Nervous system disorders
Vasovagal attack
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Psychiatric disorders
Agitation
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Psychiatric disorders
Anxiety
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Psychiatric disorders
Depression
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Psychiatric disorders
Insomnia
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Psychiatric disorders
Libido decreased
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Renal and urinary disorders
Haematuria
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Renal and urinary disorders
Incontinence NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Renal and urinary disorders
Polyuria
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Renal and urinary disorders
Renal failure NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Breath sounds decreased
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
9.4%
3/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.9%
7/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
21.9%
7/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea NOS
|
25.0%
8/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
18.8%
6/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exacerbated
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Lung crepitation
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural disorder NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum abnormal NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
4/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Skin and subcutaneous tissue disorders
Erythrosis
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Skin and subcutaneous tissue disorders
Pruritus NOS
|
18.8%
6/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Skin and subcutaneous tissue disorders
Skin eruption
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Vascular disorders
Deep venous thrombosis NOS
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Vascular disorders
Hypotension NOS
|
6.2%
2/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Vascular disorders
Lymphangitis
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Vascular disorders
Lymphoedema NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Vascular disorders
Pallor
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
18.8%
6/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Vascular disorders
Peripheral coldness
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Vascular disorders
Peripheral revascularisation
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
|
Vascular disorders
Phlebitis NOS
|
3.1%
1/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
0.00%
0/32
Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.
|
Additional Information
Clinical Development Department of PharmaMar´s Oncology,Business Unit.,
Pharma Mar, S.A.
Phone: +34 918466000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60