TriangleNCT01607957 · OUTCOME
Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths
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 the time of signing the informed consent form until the period of participant follow up (30 days following after the administration of last dose of study medication or until initiation of new antitumor therapy, whichever was earlier
What was measured
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs were events between administration of study drug and up to 30 Days that were absent before treatment or that worsened relative to pre-treatment state. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability /incapacity; congenital anomaly. The AEs were graded for severity using National Cancer Institute Common Terminology Criteria for AEs.
Analysis population: Safety analysis was performed on as treated (AT) population including all participants who took part of any dose of the study medication.
Groups in this outcome
TAS-102
Participants received TAS-102 orally with a starting dose of 35 mg/m\^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.
Placebo
Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.
| Group | Source count |
|---|---|
| TAS-102 | 533 |
| Placebo | 265 |
Reported measurements
Any adverse event (AE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TAS-102 | 98.3 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 93.2 | Not reported | Not reported | Not reported | Not reported |
Any treatment-related AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TAS-102 | 85.7 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 54.7 | Not reported | Not reported | Not reported | Not reported |
Any ≥Grade 3 AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TAS-102 | 69.4 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 51.7 | Not reported | Not reported | Not reported | Not reported |
Any treatment-related ≥Grade 3 AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TAS-102 | 49.0 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 9.8 | Not reported | Not reported | Not reported | Not reported |
Any serious AE (SAE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TAS-102 | 29.6 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 33.6 | Not reported | Not reported | Not reported | Not reported |
Any AE resulting in discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TAS-102 | 10.3 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 13.6 | Not reported | Not reported | Not reported | Not reported |
Any AE with outcome of death
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TAS-102 | 3.2 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 11.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 98.3
- group Id
- OG001
- value
- 93.2
- title
- Any adverse event (AE)
- categories
- measurements
- group Id
- OG000
- value
- 85.7
- group Id
- OG001
- value
- 54.7
- title
- Any treatment-related AE
- categories
- measurements
- group Id
- OG000
- value
- 69.4
- group Id
- OG001
- value
- 51.7
- title
- Any ≥Grade 3 AE
- categories
- measurements
- group Id
- OG000
- value
- 49.0
- group Id
- OG001
- value
- 9.8
- title
- Any treatment-related ≥Grade 3 AE
- categories
- measurements
- group Id
- OG000
- value
- 29.6
- group Id
- OG001
- value
- 33.6
- title
- Any serious AE (SAE)
- categories
- measurements
- group Id
- OG000
- value
- 10.3
- group Id
- OG001
- value
- 13.6
- title
- Any AE resulting in discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 3.2
- group Id
- OG001
- value
- 11.3
- title
- Any AE with outcome of death
- denoms
- counts
- group Id
- OG000
- value
- 533
- group Id
- OG001
- value
- 265
- units
- Participants
- description
- An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs were events between administration of study drug and up to 30 Days that were absent before treatment or that worsened relative to pre-treatment state. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability /incapacity; congenital anomaly. The AEs were graded for severity using National Cancer Institute Common Terminology Criteria for AEs.
- groups
- description
- Participants received TAS-102 orally with a starting dose of 35 mg/m\^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.
- id
- OG000
- title
- TAS-102
- description
- Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- Safety analysis was performed on as treated (AT) population including all participants who took part of any dose of the study medication.
- reporting Status
- POSTED
- time Frame
- From the time of signing the informed consent form until the period of participant follow up (30 days following after the administration of last dose of study medication or until initiation of new antitumor therapy, whichever was earlier
- title
- Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice