TriangleNCT01423760 · OUTCOME
Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Subjects
- Interval / dispersion
- Not reported
- Time frame
- Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years
What was measured
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.
Analysis population: Only subjects treated with tecemotide were included in the safety analysis set.
Groups in this outcome
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.
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.
| Group | Source count |
|---|---|
| Non-small Cell Lung Cancer (NSCLC) | 12 |
| Multiple Myeloma | 8 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | 12 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 7 | Not reported | Not reported | Not reported | Not reported |
Serious AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | 8 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 0 | Not reported | Not reported | Not reported | Not reported |
AE leading to discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | 2 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 0 | Not reported | Not reported | Not reported | Not reported |
AE leading to death
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | 3 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 7
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 0
- title
- Serious AE
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- AE leading to discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- title
- AE leading to death
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- 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.
- groups
- description
- 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.
- id
- OG000
- title
- Non-small Cell Lung Cancer (NSCLC)
- description
- 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.
- id
- OG001
- title
- Multiple Myeloma
- param Type
- NUMBER
- population Description
- Only subjects treated with tecemotide were included in the safety analysis set.
- reporting Status
- POSTED
- time Frame
- Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years
- title
- Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death
- type
- PRIMARY
- unit Of Measure
- Subjects
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice