TriangleNCT01308580 · OUTCOME
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- From first administration of study treatment until 30 days after the last administration of study treatment (Maximum duration: 48 months)
What was measured
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period. On-treatment period: The time from the first dose of treatment to 30 days after the last dose of treatment (either Cabazitaxel or Prednisone). A serious adverse event: Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03 (Grade 3 \[severe\] and Grade 4 \[life-threatening\]) was used in this study to grade clinical AEs.
Analysis population: Safety population included all randomized participants who received at least one dose of the study drug during study treatment period.
Groups in this outcome
Cabazitaxel 20 mg/m^2
Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
Cabazitaxel 25 mg/m^2
Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
| Group | Source count |
|---|---|
| Cabazitaxel 20 mg/m^2 | 580 |
| Cabazitaxel 25 mg/m^2 | 595 |
Reported measurements
Any Grade TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabazitaxel 20 mg/m^2 | 91.2 | Not reported | Not reported | Not reported | Not reported |
| Cabazitaxel 25 mg/m^2 | 93.9 | Not reported | Not reported | Not reported | Not reported |
Any Grade 3-4 TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabazitaxel 20 mg/m^2 | 39.7 | Not reported | Not reported | Not reported | Not reported |
| Cabazitaxel 25 mg/m^2 | 54.5 | Not reported | Not reported | Not reported | Not reported |
Grade 3-4 TEAE excluding laboratory TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabazitaxel 20 mg/m^2 | 35.7 | Not reported | Not reported | Not reported | Not reported |
| Cabazitaxel 25 mg/m^2 | 48.1 | Not reported | Not reported | Not reported | Not reported |
Grade 3-4 TEAE excluding DP TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabazitaxel 20 mg/m^2 | 39.0 | Not reported | Not reported | Not reported | Not reported |
| Cabazitaxel 25 mg/m^2 | 53.9 | Not reported | Not reported | Not reported | Not reported |
Grade 3-4 TEAE excluding laboratory and DP TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabazitaxel 20 mg/m^2 | 35.0 | Not reported | Not reported | Not reported | Not reported |
| Cabazitaxel 25 mg/m^2 | 47.4 | Not reported | Not reported | Not reported | Not reported |
Any Serious TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabazitaxel 20 mg/m^2 | 30.5 | Not reported | Not reported | Not reported | Not reported |
| Cabazitaxel 25 mg/m^2 | 43.2 | Not reported | Not reported | Not reported | Not reported |
Any TEAE leading to permanent discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabazitaxel 20 mg/m^2 | 16.4 | Not reported | Not reported | Not reported | Not reported |
| Cabazitaxel 25 mg/m^2 | 19.5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 91.2
- group Id
- OG001
- value
- 93.9
- title
- Any Grade TEAE
- categories
- measurements
- group Id
- OG000
- value
- 39.7
- group Id
- OG001
- value
- 54.5
- title
- Any Grade 3-4 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 35.7
- group Id
- OG001
- value
- 48.1
- title
- Grade 3-4 TEAE excluding laboratory TEAE
- categories
- measurements
- group Id
- OG000
- value
- 39.0
- group Id
- OG001
- value
- 53.9
- title
- Grade 3-4 TEAE excluding DP TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 35.0
- group Id
- OG001
- value
- 47.4
- title
- Grade 3-4 TEAE excluding laboratory and DP TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 30.5
- group Id
- OG001
- value
- 43.2
- title
- Any Serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 16.4
- group Id
- OG001
- value
- 19.5
- title
- Any TEAE leading to permanent discontinuation
- denoms
- counts
- group Id
- OG000
- value
- 580
- group Id
- OG001
- value
- 595
- units
- Participants
- description
- Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period. On-treatment period: The time from the first dose of treatment to 30 days after the last dose of treatment (either Cabazitaxel or Prednisone). A serious adverse event: Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03 (Grade 3 \[severe\] and Grade 4 \[life-threatening\]) was used in this study to grade clinical AEs.
- groups
- description
- Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
- id
- OG000
- title
- Cabazitaxel 20 mg/m^2
- description
- Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
- id
- OG001
- title
- Cabazitaxel 25 mg/m^2
- param Type
- NUMBER
- population Description
- Safety population included all randomized participants who received at least one dose of the study drug during study treatment period.
- reporting Status
- POSTED
- time Frame
- From first administration of study treatment until 30 days after the last administration of study treatment (Maximum duration: 48 months)
- title
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice