Trial Outcomes & Findings for A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiting (NCT NCT02517021)
NCT ID: NCT02517021
Last Updated: 2018-06-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
405 participants
Primary outcome timeframe
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.
Results posted on
2018-06-20
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
202
|
|
Overall Study
COMPLETED
|
120
|
117
|
|
Overall Study
NOT COMPLETED
|
83
|
85
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiting
Baseline characteristics by cohort
| Measure |
Pro-netupitant/Palonosetron Plus Dexamethasone
n=203 Participants
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
n=201 Participants
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
|
Total
n=404 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
201 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
401 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG performance status
Grade 0
|
81 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
ECOG performance status
Grade 1
|
117 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
ECOG performance status
Grade 2
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Alcohol consumption
None
|
126 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Alcohol consumption
Occasional
|
76 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Alcohol consumption
Regular
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Tobacco consumption
Non-smoker
|
83 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Tobacco consumption
Ex-smoker
|
62 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Tobacco consumption
Occasional
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Tobacco consumption
Regular
|
58 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
Pro-netupitant/Palonosetron Plus Dexamethasone
n=203 Participants
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
n=201 Participants
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
|
|---|---|---|
|
Percentage of Patients With Adverse Events
TEAE leading to death
|
10 Participants
|
14 Participants
|
|
Percentage of Patients With Adverse Events
Any TEAE
|
169 Participants
|
174 Participants
|
|
Percentage of Patients With Adverse Events
Severe TEAE
|
86 Participants
|
90 Participants
|
|
Percentage of Patients With Adverse Events
TEAE leading to discontinuation from the study
|
16 Participants
|
20 Participants
|
|
Percentage of Patients With Adverse Events
Serious TEAE
|
41 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: 0-24 hoursOutcome measures
| Measure |
Pro-netupitant/Palonosetron Plus Dexamethasone
n=203 Participants
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
n=201 Participants
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
|
|---|---|---|
|
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase
|
188 Participants
|
182 Participants
|
SECONDARY outcome
Timeframe: >24-120 hoursOutcome measures
| Measure |
Pro-netupitant/Palonosetron Plus Dexamethasone
n=203 Participants
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
n=201 Participants
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
|
|---|---|---|
|
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase
|
159 Participants
|
176 Participants
|
SECONDARY outcome
Timeframe: 0-120 hoursOutcome measures
| Measure |
Pro-netupitant/Palonosetron Plus Dexamethasone
n=203 Participants
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
n=201 Participants
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
|
|---|---|---|
|
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase
|
156 Participants
|
169 Participants
|
SECONDARY outcome
Timeframe: 0-24 hoursOutcome measures
| Measure |
Pro-netupitant/Palonosetron Plus Dexamethasone
n=203 Participants
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
n=201 Participants
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
|
|---|---|---|
|
Percentage of Patients With no Emetic Episodes in the Acute Phase
|
164 Participants
|
165 Participants
|
SECONDARY outcome
Timeframe: >24-120 hoursOutcome measures
| Measure |
Pro-netupitant/Palonosetron Plus Dexamethasone
n=203 Participants
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
n=201 Participants
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
|
|---|---|---|
|
Percentage of Patients With no Emetic Episodes in the Delayed Phase
|
173 Participants
|
184 Participants
|
SECONDARY outcome
Timeframe: 0-120 hoursOutcome measures
| Measure |
Pro-netupitant/Palonosetron Plus Dexamethasone
n=203 Participants
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
n=201 Participants
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
|
|---|---|---|
|
Percentage of Patients With no Emetic Episodes in the Overall Phase
|
171 Participants
|
178 Participants
|
SECONDARY outcome
Timeframe: 0-24 hoursOutcome measures
| Measure |
Pro-netupitant/Palonosetron Plus Dexamethasone
n=203 Participants
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
n=201 Participants
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
|
|---|---|---|
|
Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Acute Phase
|
183 Participants
|
187 Participants
|
SECONDARY outcome
Timeframe: >24-120 hoursOutcome measures
| Measure |
Pro-netupitant/Palonosetron Plus Dexamethasone
n=203 Participants
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
n=201 Participants
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
|
|---|---|---|
|
Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Delayed Phase
|
165 Participants
|
179 Participants
|
SECONDARY outcome
Timeframe: 0-120 hoursOutcome measures
| Measure |
Pro-netupitant/Palonosetron Plus Dexamethasone
n=203 Participants
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
n=201 Participants
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
|
|---|---|---|
|
Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Overall Phase
|
161 Participants
|
174 Participants
|
Adverse Events
Pro-netupitant/Palonosetron Plus Dexamethasone
Serious events: 41 serious events
Other events: 169 other events
Deaths: 10 deaths
Netupitant/Palonosetron Plus Dexamethasone
Serious events: 43 serious events
Other events: 174 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Pro-netupitant/Palonosetron Plus Dexamethasone
n=203 participants at risk
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
n=201 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/203 • 10 months
|
2.0%
4/201 • 10 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.5%
3/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.0%
6/203 • 10 months
|
4.0%
8/201 • 10 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.49%
1/203 • 10 months
|
2.0%
4/201 • 10 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.49%
1/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Cardiac disorders
Cardiac failure
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Cardiac disorders
Extrasystoles
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Eye disorders
Diplopia
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/203 • 10 months
|
1.00%
2/201 • 10 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/203 • 10 months
|
1.00%
2/201 • 10 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Gastrointestinal disorders
Nausea
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Gastrointestinal disorders
Vomiting
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
General disorders
Asthenia
|
0.49%
1/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
General disorders
Death
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
General disorders
Disease progression
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
General disorders
Fatigue
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
General disorders
General physical health deterioration
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
General disorders
Pyrexia
|
1.5%
3/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
General disorders
Sudden death
|
0.49%
1/203 • 10 months
|
1.5%
3/201 • 10 months
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Infections and infestations
Bronchitis
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Infections and infestations
Infection
|
0.49%
1/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Infections and infestations
Pharyngitis
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Infections and infestations
Pneumonia
|
3.0%
6/203 • 10 months
|
2.0%
4/201 • 10 months
|
|
Infections and infestations
Pyopneumothorax
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Infections and infestations
Respiratory tract infection
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/203 • 10 months
|
1.5%
3/201 • 10 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/203 • 10 months
|
2.0%
4/201 • 10 months
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Investigations
Blood creatinine increased
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Investigations
Neutrophil count decreased
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.99%
2/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/203 • 10 months
|
1.00%
2/201 • 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.49%
1/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.49%
1/203 • 10 months
|
1.00%
2/201 • 10 months
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Renal and urinary disorders
Renal failure
|
0.49%
1/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/203 • 10 months
|
0.50%
1/201 • 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/203 • 10 months
|
1.00%
2/201 • 10 months
|
|
Vascular disorders
Haemorrhage
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
|
Vascular disorders
Peripheral embolism
|
0.49%
1/203 • 10 months
|
0.00%
0/201 • 10 months
|
Other adverse events
| Measure |
Pro-netupitant/Palonosetron Plus Dexamethasone
n=203 participants at risk
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
n=201 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.3%
33/203 • 10 months
|
18.9%
38/201 • 10 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.3%
21/203 • 10 months
|
10.9%
22/201 • 10 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.0%
61/203 • 10 months
|
28.9%
58/201 • 10 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.9%
8/203 • 10 months
|
5.5%
11/201 • 10 months
|
|
Gastrointestinal disorders
Constipation
|
10.3%
21/203 • 10 months
|
12.9%
26/201 • 10 months
|
|
Gastrointestinal disorders
Nausea
|
9.9%
20/203 • 10 months
|
7.0%
14/201 • 10 months
|
|
General disorders
Asthenia
|
6.4%
13/203 • 10 months
|
8.5%
17/201 • 10 months
|
|
General disorders
Fatigue
|
8.9%
18/203 • 10 months
|
8.5%
17/201 • 10 months
|
|
Investigations
Alanine aminotransferase increased
|
7.4%
15/203 • 10 months
|
11.9%
24/201 • 10 months
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
12/203 • 10 months
|
9.5%
19/201 • 10 months
|
|
Investigations
Blood creatinine increased
|
5.9%
12/203 • 10 months
|
3.0%
6/201 • 10 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.4%
7/203 • 10 months
|
5.5%
11/201 • 10 months
|
|
Nervous system disorders
Headache
|
5.4%
11/203 • 10 months
|
4.5%
9/201 • 10 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.8%
32/203 • 10 months
|
14.4%
29/201 • 10 months
|
|
Vascular disorders
Hypertension
|
3.9%
8/203 • 10 months
|
6.5%
13/201 • 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60