TriangleNCT02514447 · OUTCOME
Occurrence of Pulmonary Infection Serious Adverse Events (SAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
What was measured
Percentage of patients experiencing an SAE that codes to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of Infections and Infestations and falls into a preferred term (PT) categorized as a pulmonary infection custom MedDRA query (CMQ)
Analysis population: The intent-to-treat (ITT) analysis set: All enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.
Groups in this outcome
Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b
Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Placebos Topotecan
Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a
Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²). Trilaciclib Topotecan
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b
Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Trilaciclib Topotecan
Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1
Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.50 mg/m²).
Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1
Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.25 mg/m²).
Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1
Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1
Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1
Patients received trilaciclib (280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1
Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.0 mg/m²).
| Group | Source count |
|---|---|
| Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | 29 |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | 30 |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | 32 |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | 2 |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | 3 |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | 4 |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | 8 |
| Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | 7 |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | 1 | Not reported | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | 1 | Not reported | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | 1 | Not reported | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 32
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 8
- units
- Participants
- description
- Percentage of patients experiencing an SAE that codes to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of Infections and Infestations and falls into a preferred term (PT) categorized as a pulmonary infection custom MedDRA query (CMQ)
- groups
- description
- Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Placebos Topotecan
- id
- OG000
- title
- Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b
- description
- Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²). Trilaciclib Topotecan
- id
- OG001
- title
- Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a
- description
- Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Trilaciclib Topotecan
- id
- OG002
- title
- Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b
- description
- Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.50 mg/m²).
- id
- OG003
- title
- Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1
- description
- Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.25 mg/m²).
- id
- OG004
- title
- Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1
- description
- Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
- id
- OG005
- title
- Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1
- description
- Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
- id
- OG006
- title
- Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1
- description
- Patients received trilaciclib (280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
- id
- OG007
- title
- Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1
- description
- Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.0 mg/m²).
- id
- OG008
- title
- Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The intent-to-treat (ITT) analysis set: All enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.
- reporting Status
- POSTED
- time Frame
- During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
- title
- Occurrence of Pulmonary Infection Serious Adverse Events (SAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice