TriangleNCT02517021 · OUTCOME
Percentage of Patients With Adverse Events
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
- Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 14 weeks assuming a maximum of 4 chemotherapy cycles given every 3 weeks.
What was measured
This is a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients are randomized according to a 1:1 ratio (IV NEPA FDC : oral NEPA FDC). No formal comparison is planned, the presence of a control in the same patient population helps interpret any unexpected safety finding in the experimental arm. It is expected that the number of patients randomized to the test group, i.e., 200, will allow approximately 100 patients to be treated with the test drug for 4 cycles. Based on 100 patients treated at Cycle 4 with the IV NEPA FDC , if a given Adverse Event (AE) is not observed, an AE incidence of 3% or greater can be excluded with 95% confidence.
Groups in this outcome
Pro-netupitant/Palonosetron Plus Dexamethasone
Intravenous Pro-netupitant/Palonosetron (260 mg/0.25 mg) powder for solution for infusion (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle Pro-netupitant/Palonosetron Dexamethasone
Netupitant/Palonosetron Plus Dexamethasone
Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle Netupitant/Palonosetron Dexamethasone
| Group | Source count |
|---|---|
| Pro-netupitant/Palonosetron Plus Dexamethasone | 203 |
| Netupitant/Palonosetron Plus Dexamethasone | 201 |
Reported measurements
Any TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pro-netupitant/Palonosetron Plus Dexamethasone | 169 | Not reported | Not reported | Not reported | Not reported |
| Netupitant/Palonosetron Plus Dexamethasone | 174 | Not reported | Not reported | Not reported | Not reported |
Severe TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pro-netupitant/Palonosetron Plus Dexamethasone | 86 | Not reported | Not reported | Not reported | Not reported |
| Netupitant/Palonosetron Plus Dexamethasone | 90 | Not reported | Not reported | Not reported | Not reported |
Serious TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pro-netupitant/Palonosetron Plus Dexamethasone | 41 | Not reported | Not reported | Not reported | Not reported |
| Netupitant/Palonosetron Plus Dexamethasone | 43 | Not reported | Not reported | Not reported | Not reported |
TEAE leading to death
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pro-netupitant/Palonosetron Plus Dexamethasone | 10 | Not reported | Not reported | Not reported | Not reported |
| Netupitant/Palonosetron Plus Dexamethasone | 14 | Not reported | Not reported | Not reported | Not reported |
TEAE leading to discontinuation from the study
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pro-netupitant/Palonosetron Plus Dexamethasone | 16 | Not reported | Not reported | Not reported | Not reported |
| Netupitant/Palonosetron Plus Dexamethasone | 20 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 169
- group Id
- OG001
- value
- 174
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 86
- group Id
- OG001
- value
- 90
- title
- Severe TEAE
- categories
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 43
- title
- Serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 14
- title
- TEAE leading to death
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 20
- title
- TEAE leading to discontinuation from the study
- denoms
- counts
- group Id
- OG000
- value
- 203
- group Id
- OG001
- value
- 201
- units
- Participants
- description
- This is a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients are randomized according to a 1:1 ratio (IV NEPA FDC : oral NEPA FDC). No formal comparison is planned, the presence of a control in the same patient population helps interpret any unexpected safety finding in the experimental arm. It is expected that the number of patients randomized to the test group, i.e., 200, will allow approximately 100 patients to be treated with the test drug for 4 cycles. Based on 100 patients treated at Cycle 4 with the IV NEPA FDC , if a given Adverse Event (AE) is not observed, an AE incidence of 3% or greater can be excluded with 95% confidence.
- groups
- description
- Intravenous Pro-netupitant/Palonosetron (260 mg/0.25 mg) powder for solution for infusion (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle Pro-netupitant/Palonosetron Dexamethasone
- id
- OG000
- title
- Pro-netupitant/Palonosetron Plus Dexamethasone
- description
- Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle Netupitant/Palonosetron Dexamethasone
- id
- OG001
- title
- Netupitant/Palonosetron Plus Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 14 weeks assuming a maximum of 4 chemotherapy cycles given every 3 weeks.
- title
- Percentage of Patients With Adverse Events
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice