TriangleNCT02643420 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and 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
- From the first dose of TC (Docetaxel + Cyclophosphamide) until 12 months after the last dose of study treatment (up to approximately 34 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 for Treatment Period is defined as adverse event with an onset date on or after the date of study drug administration through the end of treatment. TEAE for follow up is defined as any new onset or ongoing AE at the end of Treatment. 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: Safety Population included all participants who received at least one dose of any protocol-specified drug (TC, SPI-2012 or pegfilgrastim). One participant was randomized to pegfilgrastim but was given SPI-2012 in Safety Population. Data was summarized and reported separately for Treatment Period and Follow-up Period.
Groups in this outcome
Arm 1: SPI-2012 and TC -Treatment Period
Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.
Arm 2: Pegfilgrastim and TC -Treatment Period
Participants received Pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the 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 dose of 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 dose of study treatment.
| Group | Source count |
|---|---|
| Arm 1: SPI-2012 and TC -Treatment Period | 197 |
| Arm 2: Pegfilgrastim and TC -Treatment Period | 208 |
| Arm 1: SPI-2012 and TC - Follow up Period | 197 |
| Arm 2: Pegfilgrastim and TC - Follow up Period | 208 |
Reported measurements
TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: SPI-2012 and TC -Treatment Period | 192 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Pegfilgrastim and TC -Treatment Period | 204 | Not reported | Not reported | Not reported | Not reported |
| Arm 1: SPI-2012 and TC - Follow up Period | 95 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Pegfilgrastim and TC - Follow up Period | 83 | Not reported | Not reported | Not reported | Not reported |
SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: SPI-2012 and TC -Treatment Period | 36 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Pegfilgrastim and TC -Treatment Period | 29 | Not reported | Not reported | Not reported | Not reported |
| Arm 1: SPI-2012 and TC - Follow up Period | 8 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Pegfilgrastim and TC - Follow up Period | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 192
- group Id
- OG001
- value
- 204
- group Id
- OG002
- value
- 95
- group Id
- OG003
- value
- 83
- title
- TEAE
- categories
- measurements
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 2
- title
- SAE
- denoms
- counts
- group Id
- OG000
- value
- 197
- group Id
- OG001
- value
- 208
- group Id
- OG002
- value
- 197
- group Id
- OG003
- value
- 208
- 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 for Treatment Period is defined as adverse event with an onset date on or after the date of study drug administration through the end of treatment. TEAE for follow up is defined as any new onset or ongoing AE at the end of Treatment. 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
- Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.
- id
- OG000
- title
- Arm 1: SPI-2012 and TC -Treatment Period
- description
- Participants received Pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.
- id
- OG001
- title
- Arm 2: Pegfilgrastim and TC -Treatment Period
- description
- In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of 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 dose of study treatment.
- id
- OG003
- title
- Arm 2: Pegfilgrastim and TC - Follow up Period
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population included all participants who received at least one dose of any protocol-specified drug (TC, SPI-2012 or pegfilgrastim). One participant was randomized to pegfilgrastim but was given SPI-2012 in Safety Population. Data was summarized and reported separately for Treatment Period and Follow-up Period.
- reporting Status
- POSTED
- time Frame
- From the first dose of TC (Docetaxel + Cyclophosphamide) until 12 months after the last dose of study treatment (up to approximately 34 months)
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice