TriangleNCT01376297 · 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
- NUMBER
- Unit
- percentage of patients with TEAE
- Interval / dispersion
- Not reported
- Time frame
- Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 24 weeks assuming 6 chemotherapy cycles given every 4 weeks
What was measured
This was a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients were randomized according to a 3:1 ratio (netupitant/palonosetron:aprepitant/palonosetron). No formal comparison was planned, the presence of a control in the same patient population helped interpret any unexpected safety finding in the experimental arm.The number of patients was estimated in order to have more than 100 patients treated with the netupitant/palonosetron comination for up to at least six cycles. Based on 100 patients, if a given AE is not observed, an AE incidence of 3% or greater can be excluded with 95% confidence.
Analysis population: Safety Population
Groups in this outcome
Netupitant and 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 and Palonosetron Dexamethasone
Aprepitant and Palonosetron Plus Dexamethasone
Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle. Aprepitant Palonosetron Dexamethasone
| Group | Source count |
|---|---|
| Netupitant and Palonosetron Plus Dexamethasone | 308 |
| Aprepitant and Palonosetron Plus Dexamethasone | 104 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Netupitant and Palonosetron Plus Dexamethasone | 86.0 | Not reported | Not reported | Not reported | Not reported |
| Aprepitant and Palonosetron Plus Dexamethasone | 91.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 86.0
- group Id
- OG001
- value
- 91.3
- denoms
- counts
- group Id
- OG000
- value
- 308
- group Id
- OG001
- value
- 104
- units
- Participants
- description
- This was a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients were randomized according to a 3:1 ratio (netupitant/palonosetron:aprepitant/palonosetron). No formal comparison was planned, the presence of a control in the same patient population helped interpret any unexpected safety finding in the experimental arm.The number of patients was estimated in order to have more than 100 patients treated with the netupitant/palonosetron comination for up to at least six cycles. Based on 100 patients, if a given AE is not observed, an AE incidence of 3% or greater can be excluded with 95% confidence.
- groups
- description
- Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle Netupitant and Palonosetron Dexamethasone
- id
- OG000
- title
- Netupitant and Palonosetron Plus Dexamethasone
- description
- Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle. Aprepitant Palonosetron Dexamethasone
- id
- OG001
- title
- Aprepitant and Palonosetron Plus Dexamethasone
- param Type
- NUMBER
- population Description
- Safety Population
- reporting Status
- POSTED
- time Frame
- Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 24 weeks assuming 6 chemotherapy cycles given every 4 weeks
- title
- Percentage of Patients With Adverse Events
- type
- PRIMARY
- unit Of Measure
- percentage of patients with TEAE
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice