Trial Outcomes & Findings for Study of Tecemotide (L-BLP25) in Participants With Stage III Unresectable Non-small Cell Lung Cancer (NSCLC) Following Primary Chemoradiotherapy (NCT NCT00960115)
NCT ID: NCT00960115
Last Updated: 2015-10-21
Results Overview
OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (01 May 2014), whichever was earlier.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
178 participants
Primary outcome timeframe
Time from randomization to death or last day known to be alive reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).
Results posted on
2015-10-21
Participant Flow
First/last subject (informed consent, Step 2 \[randomized part\]): 03 Feb 2010/15 Feb 2012. Clinical data cut-off: 01 May 2014. Study completion date: 15 June 2015
Enrolled: 197 screened for eligibility; 25 excluded (mainly due to non-fulfillment of inclusion or exclusion criteria) and 172 subjects randomized.
Participant milestones
| Measure |
Tecemotide (L-BLP25) + Cyclophosphamide
Single dose of cyclophosphamide (300 milligrams per square meter \[mg/m\^2\] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 microgram \[mcg\]) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until progressive disease (PD) was documented.
|
Placebo + Saline
Single dose of saline (sodium chloride, 9 grams per liter \[g/L\]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
58
|
|
Overall Study
COMPLETED
|
95
|
43
|
|
Overall Study
NOT COMPLETED
|
19
|
15
|
Reasons for withdrawal
| Measure |
Tecemotide (L-BLP25) + Cyclophosphamide
Single dose of cyclophosphamide (300 milligrams per square meter \[mg/m\^2\] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 microgram \[mcg\]) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until progressive disease (PD) was documented.
|
Placebo + Saline
Single dose of saline (sodium chloride, 9 grams per liter \[g/L\]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
|
|---|---|---|
|
Overall Study
Ongoing treatment at data cut-off date
|
19
|
15
|
Baseline Characteristics
Study of Tecemotide (L-BLP25) in Participants With Stage III Unresectable Non-small Cell Lung Cancer (NSCLC) Following Primary Chemoradiotherapy
Baseline characteristics by cohort
| Measure |
Tecemotide (L-BLP25) + Cyclophosphamide
n=114 Participants
Single dose of cyclophosphamide (300 milligrams per square meter \[mg/m\^2\] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
|
Placebo + Saline
n=58 Participants
Single dose of saline (sodium chloride, 9 grams per liter \[g/L\]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.0 Years
STANDARD_DEVIATION 9.31 • n=5 Participants
|
60.1 Years
STANDARD_DEVIATION 9.81 • n=7 Participants
|
62.0 Years
STANDARD_DEVIATION 9.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to death or last day known to be alive reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).Population: ITT analysis set included all subjects randomly allocated to a treatment (tecemotide \[L-BLP25\] or placebo).
OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (01 May 2014), whichever was earlier.
Outcome measures
| Measure |
Tecemotide (L-BLP25) + Cyclophosphamide
n=114 Participants
Single dose of cyclophosphamide (300 milligrams per square meter \[mg/m\^2\] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
|
Placebo + Saline
n=58 Participants
Single dose of saline (sodium chloride, 9 grams per liter \[g/L\]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
|
|---|---|---|
|
Overall Survival (OS) Time
|
32.4 Months
Interval 26.7 to
Since there were not enough participants with an event, the upper limit was not estimable.
|
32.2 Months
Interval 19.6 to
Since there were not enough participants with an event, the upper limit was not estimable.
|
SECONDARY outcome
Timeframe: Time from randomization to PD, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).Population: ITT Analysis Set included all subjects randomly allocated to a treatment (tecemotide \[L-BLP25\] or placebo).
TTP was defined as the time from date of randomization to date of radiological diagnosis of PD (based on Response Evaluation Criteria in Solid Tumors \[RECIST\] v1.0). In the event that radiological confirmation could not be obtained but participant was withdrawn from trial treatment or died due to disease progression, TTP was measured from date of randomization to the date of discontinuation of trial treatment. Participants without event who died from causes other than disease progression were censored at date of death. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration. Participants without event with ongoing treatment at time of analysis, or who had stopped treatment for reasons other than PD, were censored on the date of last treatment administration.
Outcome measures
| Measure |
Tecemotide (L-BLP25) + Cyclophosphamide
n=114 Participants
Single dose of cyclophosphamide (300 milligrams per square meter \[mg/m\^2\] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
|
Placebo + Saline
n=58 Participants
Single dose of saline (sodium chloride, 9 grams per liter \[g/L\]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
|
|---|---|---|
|
Time To Progression (TTP) - Investigator Read
|
11.3 Months
Interval 6.5 to 12.9
|
7.0 Months
Interval 5.8 to 14.2
|
SECONDARY outcome
Timeframe: Time from randomization to disease progression, death or last tumor assessment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).Population: ITT analysis set included all subjects randomly allocated to a treatment (tecemotide \[L-BLP25\] or placebo).
PFS time was defined as the duration from randomization to either first observation of objective PD (based on RECIST v1.0) or occurrence of death due to any cause. Participants without event still on treatment at time of analysis, or who stopped treatment for reasons other than PD or PD without radiological confirmed progression, were censored at the last imaging date. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration.
Outcome measures
| Measure |
Tecemotide (L-BLP25) + Cyclophosphamide
n=114 Participants
Single dose of cyclophosphamide (300 milligrams per square meter \[mg/m\^2\] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
|
Placebo + Saline
n=58 Participants
Single dose of saline (sodium chloride, 9 grams per liter \[g/L\]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
|
|---|---|---|
|
Progression Free Survival (PFS) Time - Investigator Read
|
11.6 Months
Interval 6.9 to 13.9
|
8.0 Months
Interval 5.9 to 14.2
|
SECONDARY outcome
Timeframe: Time from randomization to discontinuation of trial treatment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).Population: ITT analysis set included all subjects randomly allocated to a treatment (tecemotide \[L-BLP25\] or placebo).
TTF was defined as the duration from date of randomization to the date of discontinuation of any trial treatment (cyclophosphamide or saline, tecemotide \[L-BLP25\] or placebo vaccine) for any reason as reported by the Investigator. Participants who had missed 2 consecutive scheduled doses and were subsequently lost to follow-up were considered as treatment failures with event date as date of first missed administration. Participants without event still on treatment at time of analysis were censored on the date of last treatment administration.
Outcome measures
| Measure |
Tecemotide (L-BLP25) + Cyclophosphamide
n=114 Participants
Single dose of cyclophosphamide (300 milligrams per square meter \[mg/m\^2\] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
|
Placebo + Saline
n=58 Participants
Single dose of saline (sodium chloride, 9 grams per liter \[g/L\]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
|
|---|---|---|
|
Time to Treatment Failure (TTF)
|
8.0 Months
Interval 4.6 to 11.5
|
6.2 Months
Interval 3.2 to 11.5
|
Adverse Events
Tecemotide (L-BLP25) + Cyclophosphamide
Serious events: 24 serious events
Other events: 107 other events
Deaths: 0 deaths
Placebo + Saline
Serious events: 12 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tecemotide (L-BLP25) + Cyclophosphamide
n=114 participants at risk
Single dose of cyclophosphamide (300 milligrams per square meter \[mg/m\^2\] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
|
Placebo + Saline
n=57 participants at risk
Single dose of saline (sodium chloride, 9 grams per liter \[g/L\]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Cardiac disorders
Cardiac failure
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/114 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
1.8%
1/57 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Endocrine disorders
Hypothyroidism
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Eye disorders
Cataract
|
0.00%
0/114 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
1.8%
1/57 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/114 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
1.8%
1/57 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Gingival cyst
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Vomiting
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/114 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
1.8%
1/57 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Infections and infestations
Pneumonia
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
5.3%
3/57 • Number of events 3 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/114 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
1.8%
1/57 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/114 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
1.8%
1/57 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
1.8%
2/114 • Number of events 2 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
3.5%
2/57 • Number of events 2 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.00%
0/114 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
1.8%
1/57 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/114 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
1.8%
1/57 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/114 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
1.8%
1/57 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Nervous system disorders
Loss of consciousness
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Psychiatric disorders
Suicide attempt
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
Other adverse events
| Measure |
Tecemotide (L-BLP25) + Cyclophosphamide
n=114 participants at risk
Single dose of cyclophosphamide (300 milligrams per square meter \[mg/m\^2\] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
|
Placebo + Saline
n=57 participants at risk
Single dose of saline (sodium chloride, 9 grams per liter \[g/L\]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
|
|---|---|---|
|
Eye disorders
Cataract
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
5.3%
3/57 • Number of events 3 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Constipation
|
10.5%
12/114 • Number of events 12 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
3.5%
2/57 • Number of events 2 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Dental caries
|
1.8%
2/114 • Number of events 2 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
5.3%
3/57 • Number of events 3 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.4%
13/114 • Number of events 13 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
8.8%
5/57 • Number of events 5 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Nausea
|
11.4%
13/114 • Number of events 13 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
7.0%
4/57 • Number of events 4 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Stomatitis
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
7.0%
4/57 • Number of events 4 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
General disorders
Fatigue
|
6.1%
7/114 • Number of events 7 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
10.5%
6/57 • Number of events 6 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
General disorders
Influenza like illness
|
6.1%
7/114 • Number of events 7 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
5.3%
3/57 • Number of events 3 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
General disorders
Injection site erythema
|
8.8%
10/114 • Number of events 10 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
1.8%
1/57 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
General disorders
Injection site nodule
|
7.9%
9/114 • Number of events 9 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
0.00%
0/57 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
General disorders
Malaise
|
7.0%
8/114 • Number of events 8 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
8.8%
5/57 • Number of events 5 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
General disorders
Non-cardiac chest pain
|
1.8%
2/114 • Number of events 2 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
5.3%
3/57 • Number of events 3 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
General disorders
Pyrexia
|
4.4%
5/114 • Number of events 5 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
5.3%
3/57 • Number of events 3 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
7.9%
9/114 • Number of events 9 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
3.5%
2/57 • Number of events 2 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Infections and infestations
Herpes zoster
|
5.3%
6/114 • Number of events 6 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
5.3%
3/57 • Number of events 3 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Infections and infestations
Nasopharyngitis
|
28.9%
33/114 • Number of events 33 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
28.1%
16/57 • Number of events 16 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
6/114 • Number of events 6 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
3.5%
2/57 • Number of events 2 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
31.6%
36/114 • Number of events 36 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
24.6%
14/57 • Number of events 14 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Investigations
Weight increased
|
6.1%
7/114 • Number of events 7 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
1.8%
1/57 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.5%
12/114 • Number of events 12 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
1.8%
1/57 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.88%
1/114 • Number of events 1 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
8.8%
5/57 • Number of events 5 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.8%
2/114 • Number of events 2 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
10.5%
6/57 • Number of events 6 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
7/114 • Number of events 7 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
5.3%
3/57 • Number of events 3 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.6%
3/114 • Number of events 3 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
5.3%
3/57 • Number of events 3 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.2%
15/114 • Number of events 15 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
15.8%
9/57 • Number of events 9 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.0%
8/114 • Number of events 8 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
5.3%
3/57 • Number of events 3 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Psychiatric disorders
Insomnia
|
3.5%
4/114 • Number of events 4 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
8.8%
5/57 • Number of events 5 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.9%
9/114 • Number of events 9 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
5.3%
3/57 • Number of events 3 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.4%
5/114 • Number of events 5 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
5.3%
3/57 • Number of events 3 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.0%
8/114 • Number of events 8 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
12.3%
7/57 • Number of events 7 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
|
Vascular disorders
Hypertension
|
2.6%
3/114 • Number of events 3 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
10.5%
6/57 • Number of events 6 • Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide \[L-BLP25\] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
|
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
- Publication restrictions are in place
Restriction type: OTHER