TriangleNCT02499770 · OUTCOME
Occurrence of Infectious SAEs in Part 2
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
- From randomization to the end of the treatment period (a minimum of 51 days up to a maximum of 379 days)
What was measured
SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect. An infectious SAE was a serious event in the MedDRA system organ class "infections and infestations" and a preferred term of anal abscess, bacteraemia, bronchitis, candida infection, chronic sinusitis, conjunctivitis, infection, influenza, nasopharyngitis, oral candidiasis, oral herpes, pharyngitis streptococcal, pneumonia, pneumonia bacterial, respiratory tract infection, sepsis, skin infection, upper respiratory tract infection, urinary tract infection, urosepsis or viral upper respiratory tract infection.
Analysis population: The FAS included all randomized patients who received at least 1 dose of study drug (etoposide, carboplatin, or trilaciclib). Analyses using the FAS were conducted on the basis of the assigned treatment.
Groups in this outcome
Part 2: Placebo
Participants received placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
Part 2: Trilaciclib 240 mg/m^2
Participants received trilaciclib 240 mg/m\^2 IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
| Group | Source count |
|---|---|
| Part 2: Placebo | 37 |
| Part 2: Trilaciclib 240 mg/m^2 | 38 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Trilaciclib 240 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 38
- units
- Participants
- description
- SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect. An infectious SAE was a serious event in the MedDRA system organ class "infections and infestations" and a preferred term of anal abscess, bacteraemia, bronchitis, candida infection, chronic sinusitis, conjunctivitis, infection, influenza, nasopharyngitis, oral candidiasis, oral herpes, pharyngitis streptococcal, pneumonia, pneumonia bacterial, respiratory tract infection, sepsis, skin infection, upper respiratory tract infection, urinary tract infection, urosepsis or viral upper respiratory tract infection.
- groups
- description
- Participants received placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
- id
- OG000
- title
- Part 2: Placebo
- description
- Participants received trilaciclib 240 mg/m\^2 IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
- id
- OG001
- title
- Part 2: Trilaciclib 240 mg/m^2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The FAS included all randomized patients who received at least 1 dose of study drug (etoposide, carboplatin, or trilaciclib). Analyses using the FAS were conducted on the basis of the assigned treatment.
- reporting Status
- POSTED
- time Frame
- From randomization to the end of the treatment period (a minimum of 51 days up to a maximum of 379 days)
- title
- Occurrence of Infectious SAEs in Part 2
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice