TriangleNCT02953340 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death
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
- Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
What was measured
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product or study procedure, whether or not considered related to the medicinal product. A TEAE is any AE that occurred from the first dose of study treatment through 12 months after the last dose of study treatment or 35 (±5) days after date of participant early discontinuation. SAE is defined as any AE which meets any of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, includes important medical events.
Analysis population: SAF population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Data was summarized and reported for Treatment and Follow-up period separately for both groups.
Groups in this outcome
(Arm 1): SPI-2012 and TC
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation.
(Arm 2): Pegfilgrastim and TC
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation.
(Arm 1): SPI-2012 and TC: Follow-up Period
In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.
Arm 2: Pegfilgrastim and TC: Follow-up Period
In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment
| Group | Source count |
|---|---|
| (Arm 1): SPI-2012 and TC | 117 |
| (Arm 2): Pegfilgrastim and TC | 118 |
| (Arm 1): SPI-2012 and TC: Follow-up Period | 117 |
| Arm 2: Pegfilgrastim and TC: Follow-up Period | 118 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| (Arm 1): SPI-2012 and TC | 115 | Not reported | Not reported | Not reported | Not reported |
| (Arm 2): Pegfilgrastim and TC | 116 | Not reported | Not reported | Not reported | Not reported |
| (Arm 1): SPI-2012 and TC: Follow-up Period | 33 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Pegfilgrastim and TC: Follow-up Period | 48 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| (Arm 1): SPI-2012 and TC | 12 | Not reported | Not reported | Not reported | Not reported |
| (Arm 2): Pegfilgrastim and TC | 19 | Not reported | Not reported | Not reported | Not reported |
| (Arm 1): SPI-2012 and TC: Follow-up Period | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Pegfilgrastim and TC: Follow-up Period | 4 | Not reported | Not reported | Not reported | Not reported |
Death
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| (Arm 1): SPI-2012 and TC | 0 | Not reported | Not reported | Not reported | Not reported |
| (Arm 2): Pegfilgrastim and TC | 1 | Not reported | Not reported | Not reported | Not reported |
| (Arm 1): SPI-2012 and TC: Follow-up Period | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Pegfilgrastim and TC: Follow-up Period | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 115
- group Id
- OG001
- value
- 116
- group Id
- OG002
- value
- 33
- group Id
- OG003
- value
- 48
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 4
- title
- SAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Death
- denoms
- counts
- group Id
- OG000
- value
- 117
- group Id
- OG001
- value
- 118
- group Id
- OG002
- value
- 117
- group Id
- OG003
- value
- 118
- units
- Participants
- description
- An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product or study procedure, whether or not considered related to the medicinal product. A TEAE is any AE that occurred from the first dose of study treatment through 12 months after the last dose of study treatment or 35 (±5) days after date of participant early discontinuation. SAE is defined as any AE which meets any of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, includes important medical events.
- groups
- description
- At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation.
- id
- OG000
- title
- (Arm 1): SPI-2012 and TC
- description
- At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation.
- id
- OG001
- title
- (Arm 2): Pegfilgrastim and TC
- description
- In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.
- id
- OG002
- title
- (Arm 1): SPI-2012 and TC: Follow-up Period
- description
- In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment
- id
- OG003
- title
- Arm 2: Pegfilgrastim and TC: Follow-up Period
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- SAF population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Data was summarized and reported for Treatment and Follow-up period separately for both groups.
- reporting Status
- POSTED
- time Frame
- Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice