Trial Outcomes & Findings for Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease (NCT NCT00157196)
NCT ID: NCT00157196
Last Updated: 2015-08-18
Results Overview
TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs with Cancer and Leukemia Group B Extended Clinical Toxicity Criteria (CALGB-ECTC) Grade 3 or 4 were also reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Up to data cut-off date (17 September 2007)
Results posted on
2015-08-18
Participant Flow
First/last participant (informed consent): April 2005/September 2005. Last participant completed: April 2012; Clinical data cut-off: 17 September 2007. The study was conducted at 8 centers in Canada.
Enrolled: 22 participants.
Participant milestones
| Measure |
Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care
A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 microgram (mcg) of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The best standard of care (BSC) was provided at the investigator's discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care
A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 microgram (mcg) of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The best standard of care (BSC) was provided at the investigator's discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
|
|---|---|
|
Overall Study
Ongoing at data cut-off
|
9
|
Baseline Characteristics
Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease
Baseline characteristics by cohort
| Measure |
Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care
n=22 Participants
A single intravenous infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator's discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
|
|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 9.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to data cut-off date (17 September 2007)Population: Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment.
TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs with Cancer and Leukemia Group B Extended Clinical Toxicity Criteria (CALGB-ECTC) Grade 3 or 4 were also reported.
Outcome measures
| Measure |
Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care
n=22 Participants
A single intravenous infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator's discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs)
TEAEs
|
22 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs)
Serious TEAEs
|
4 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs)
TEAEs with CALGB-ECTC Grade 3 or 4
|
13 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs)
TEAEs leading to death
|
1 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs)
ISRs
|
11 participants
|
SECONDARY outcome
Timeframe: Up to data cut-off date (17 September 2007)Population: Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment.
Survival time was to be measured from study entry (date of cyclophosphamide administration) to date of death. For subjects alive or lost to follow-up at time of analysis, the time between date of cyclophosphamide administration and date on which the subject was last known alive was to be calculated and used as a censored observation in the analysis.
Outcome measures
| Measure |
Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care
n=22 Participants
A single intravenous infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator's discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
|
|---|---|
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Survival Time
|
NA months
Interval 17.5 to
The median survival time could not be estimated as there were only eight events reported, still fewer than the 11 events necessary to estimate a median survival time.
|
SECONDARY outcome
Timeframe: Up to data cut-off date (17 September 2007)Population: Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment.
PFS was defined as duration from first administration of trial treatment until progressive disease \[PD\] (radiological or clinical, if radiological progression is not available) or death due to any cause. Participants without event were censored on the date of last tumor assessment. Clinical assessments were performed 4 weekly in primary treatment and 6 weekly in maintenance treatment.
Outcome measures
| Measure |
Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care
n=22 Participants
A single intravenous infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator's discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
|
|---|---|
|
Progression Free Survival (PFS) Time
|
NA months
Interval 5.7 to
The PFS could not be estimated as there were only eight events reported, still fewer than the 11 events necessary to estimate a median PFS
|
Adverse Events
Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care
n=22 participants at risk
A single intravenous infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator's discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
|
|---|---|
|
Cardiac disorders
Coronary artery insufficiency
|
4.5%
1/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
General disorders
Chest pain
|
4.5%
1/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Infections and infestations
Pneumonia
|
4.5%
1/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
4.5%
1/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
Other adverse events
| Measure |
Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care
n=22 participants at risk
A single intravenous infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator's discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
|
|---|---|
|
Cardiac disorders
Tachycardia
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Gastrointestinal disorders
Abdominal pain
|
13.6%
3/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Gastrointestinal disorders
Constipation
|
22.7%
5/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Gastrointestinal disorders
Diarrhoea
|
22.7%
5/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Gastrointestinal disorders
Nausea
|
45.5%
10/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Gastrointestinal disorders
Stomatitis
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
General disorders
Chest pain
|
27.3%
6/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
General disorders
Chills
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
General disorders
Early satiety
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
General disorders
Fatigue
|
54.5%
12/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
General disorders
Influenza like illness
|
27.3%
6/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
General disorders
Injection site bruising
|
22.7%
5/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
General disorders
Injection site erythema
|
22.7%
5/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
General disorders
Injection site pain
|
13.6%
3/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
General disorders
Pyrexia
|
13.6%
3/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Infections and infestations
Bronchitis
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Infections and infestations
Influenza
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Infections and infestations
Lower respiratory tract infection
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Infections and infestations
Lung infection
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Infections and infestations
Pneumonia
|
13.6%
3/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Infections and infestations
Sinusitis
|
13.6%
3/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Infections and infestations
Upper respiratory tract infection
|
31.8%
7/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Infections and infestations
Urinary tract infection
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Infections and infestations
Viral infection
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Injury, poisoning and procedural complications
Radiation fibrosis - lung
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Investigations
Weight increased
|
22.7%
5/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Metabolism and nutrition disorders
Anorexia
|
31.8%
7/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.6%
3/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
18.2%
4/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
27.3%
6/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Nervous system disorders
Dizziness
|
18.2%
4/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Nervous system disorders
Headache
|
36.4%
8/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Nervous system disorders
Hypoaesthesia
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Nervous system disorders
Neuropathy peripheral
|
13.6%
3/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Nervous system disorders
Paraesthesia
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Nervous system disorders
Sinus headache
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Psychiatric disorders
Anxiety
|
18.2%
4/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Psychiatric disorders
Insomnia
|
22.7%
5/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
45.5%
10/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
45.5%
10/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
2/22 • Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The study as a whole will be published prior to any individual investigator publications. It is required that copies of all papers, abstracts, articles, etc. that contain study data are to be forward to the Sponsor for review 30 days prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER