Trial Outcomes & Findings for Common Safety Follow-up Trial of Tecemotide (L-BLP25) (NCT NCT01423760)
NCT ID: NCT01423760
Last Updated: 2016-10-06
Results Overview
An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE is 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, AEs leading to discontinuation and AEs leading to death.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years
Results posted on
2016-10-06
Participant Flow
First/last subject (informed consent): January 2012/July 2012. Subjects randomized at 9 sites in Canada and Sweden.
Subjects who participated in the tecemotide (L-BLP25) clinical trials (EMR 63325-005, EMR 63325-006, and EMR 63325-008 served as feeder studies) were considered in this follow-up study after the protocol specific inclusion and exclusion criteria to continue their maintenance treatment. A total of 27 subjects were enrolled in this follow-up study.
Participant milestones
| Measure |
Non-small Cell Lung Cancer (NSCLC)
Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
|
Multiple Myeloma
Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
Number of Tecemotide Subjects
|
12
|
8
|
|
Overall Study
Number of Non-treatment Subjects
|
2
|
5
|
|
Overall Study
Safety Analysis Set
|
12
|
8
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Common Safety Follow-up Trial of Tecemotide (L-BLP25)
Baseline characteristics by cohort
| Measure |
Non-small Cell Lung Cancer (NSCLC)
n=14 Participants
Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
|
Multiple Myeloma
n=13 Participants
Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.7 Years
STANDARD_DEVIATION 8.98 • n=99 Participants
|
65.2 Years
STANDARD_DEVIATION 9.81 • n=107 Participants
|
66.5 Years
STANDARD_DEVIATION 9.30 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 yearsPopulation: Only subjects treated with tecemotide were included in the safety analysis set.
An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE is 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, AEs leading to discontinuation and AEs leading to death.
Outcome measures
| Measure |
Non-small Cell Lung Cancer (NSCLC)
n=12 Participants
Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
|
Multiple Myeloma
n=8 Participants
Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
|
|---|---|---|
|
Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death
AEs
|
12 Subjects
|
7 Subjects
|
|
Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death
Serious AE
|
8 Subjects
|
0 Subjects
|
|
Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death
AE leading to discontinuation
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death
AE leading to death
|
3 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: From randomization to death, assessed up to 3.6 yearsPopulation: Efficacy analysis was not performed due to the premature termination of this safety follow-up study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115)
Overall survival time was defined as the time from randomization to death. Subjects without events were censored at the last date they were known to be alive.
Outcome measures
Outcome data not reported
Adverse Events
NSCLC
Serious events: 8 serious events
Other events: 12 other events
Deaths: 0 deaths
Multiple Myeloma
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NSCLC
n=12 participants at risk
Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
|
Multiple Myeloma
n=8 participants at risk
Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Bronchopneumonia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Sepsis
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Staphylococcal infection
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Urosepsis
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Investigations
Blood creatinine increased
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Renal and urinary disorders
Acute kidney injury
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Renal and urinary disorders
Haematuria
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
Other adverse events
| Measure |
NSCLC
n=12 participants at risk
Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
|
Multiple Myeloma
n=8 participants at risk
Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Vascular disorders
Hypertension
|
33.3%
4/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
25.0%
2/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Cardiac disorders
Angina pectoris
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Cardiac disorders
Tachycardia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Ear and labyrinth disorders
Deafness
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
3/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Eye disorders
Cataract
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Eye disorders
Dry eye
|
0.00%
0/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
4/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Gastrointestinal disorders
Frequent bowel movements
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Gastrointestinal disorders
Gingival ulceration
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Gastrointestinal disorders
Large intestine polyp
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
General disorders
Fatigue
|
66.7%
8/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
General disorders
Influenza like illness
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
General disorders
Injection site erythema
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
General disorders
Injection site hypersensitivity
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
General disorders
Injection site induration
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
General disorders
Oedema peripheral
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Immune system disorders
Oral allergy syndrome
|
0.00%
0/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Immune system disorders
Seasonal allergy
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Bronchitis
|
25.0%
3/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Cystitis
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Ear infection
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Gastroenteritis viral
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Herpes zoster
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Infection parasitic
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Influenza
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Lip infection
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Lung infection
|
0.00%
0/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Mycobacterial infection
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Nail infection
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
3/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Onychomycosis
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Oral candidiasis
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Pharyngitis streptococcal
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Sinusitis
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Skin infection
|
0.00%
0/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
62.5%
5/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Urinary tract infection
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Vaginal infection
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.00%
0/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Injury, poisoning and procedural complications
Pulmonary radiation injury
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Injury, poisoning and procedural complications
Radiation fibrosis
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Injury, poisoning and procedural complications
Radiation fibrosis - lung
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Investigations
Blood creatinine increased
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Investigations
Hepatic enzyme increased
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Investigations
International normalised ratio increased
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Investigations
Oxygen saturation decreased
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Investigations
Troponin I increased
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Investigations
Weight increased
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
3/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
4/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
25.0%
2/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Musculoskeletal and connective tissue disorders
Clubbing
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Nervous system disorders
Carotid artery stenosis
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Nervous system disorders
Dizziness
|
41.7%
5/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Nervous system disorders
Dysgeusia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Nervous system disorders
Neuropathy peripheral
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Nervous system disorders
Sciatica
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Psychiatric disorders
Anxiety
|
33.3%
4/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Psychiatric disorders
Depression
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Psychiatric disorders
Insomnia
|
41.7%
5/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Renal and urinary disorders
Chronic kidney disease
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Renal and urinary disorders
Haematuria
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Renal and urinary disorders
Urinary incontinence
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Renal and urinary disorders
Urinary retention
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Reproductive system and breast disorders
Dyspareunia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Reproductive system and breast disorders
Gynaecomastia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
58.3%
7/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
12.5%
1/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
2/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
8.3%
1/12 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
0.00%
0/8 • Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator will inform the Sponsor in advance about any plans to publish or present data from the trial. Any publications and presentations of the results (abstracts in journals or newspapers, oral presentations, etc.), either in whole or in part, by Investigators or their representatives will require pre-submission review by the Sponsor.The Sponsor will not suppress or veto publications, but maintains the right to delay publication in order to protect intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER