Trial Outcomes & Findings for Observational Study on the Use of Akynzeo® in Patients Receiving HEC (NCT NCT03649230)

Last Updated: 2023-08-18

Results Overview

The Functional Living Index - Emesis questionnaire is a validated patient reported outcome with the objective of assessing the impact of chemotherapy-induced nausea and vomiting on patient's daily function. Questionnaire consists of a nausea domain and a vomiting domain of nine items each where the patient should rate how much nausea and vomiting have affected the quality of life. For each question the patient will rate how much nausea (or vomiting) has affected an aspect of his quality of life during the past five days. Each question uses a visual analogue scale (100 mm) and an ordinal scale (where 1= no emesis-7=a great deal). The minimum total score is 18 and the maximum total score is 126. Higher scores indicate less impairment on daily life as a result of nausea or vomiting. A FLIE total score \> 108 indicates no impairment on daily life as a result of nausea or vomiting. Assessed by patient following day 5 of each cycle.

Recruitment status

COMPLETED

Target enrollment

207 participants

Primary outcome timeframe

Day 5 of cycle 1

Results posted on

2023-08-18

Participant Flow

Participants were recruited from cancer treatment centers based on physician review of medical charts from the recruiting physicians clinical practice and referral from other physicians.

Participant milestones

Participant milestones
Measure	Treatment 300mg netupitant/0.5mg palonosetron hydrochloride
Overall Study STARTED	207
Overall Study COMPLETED	150
Overall Study NOT COMPLETED	57

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment 300mg netupitant/0.5mg palonosetron hydrochloride
Overall Study Adverse Event	12
Overall Study Death	8
Overall Study Withdrawal by Subject	6
Overall Study Physician Decision	5
Overall Study Disease progression	5
Overall Study Switched to non-HEC	5
Overall Study Chemotherapy discontinued	4
Overall Study Received only 3 HEC cycles	4
Overall Study Screen Failure	3
Overall Study Patient stopped treatment	2
Overall Study Protocol Violation	1
Overall Study Non-compliance	1
Overall Study Patient Received Cisplatin days 1-3 q 3 weeks	1

Baseline Characteristics

Observational Study on the Use of Akynzeo® in Patients Receiving HEC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Modified Intent-to-Treat Population n=197 Participants 300mg netupitant/0.5mg palonosetron hydrochloride
Age, Continuous	60.0 years n=5 Participants
Age, Customized Mean (SD)	58.3 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	161 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	168 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants
Race/Ethnicity, Customized Black	6 Participants n=5 Participants
Race/Ethnicity, Customized Aboriginal	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	14 Participants n=5 Participants
Race/Ethnicity, Customized other	5 Participants n=5 Participants
Region of Enrollment Canada	197 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 5 of cycle 1

Population: mITT

Outcome measures

Outcome measures
Measure	Treatment n=184 Participants 300mg netupitant/0.5mg palonosetron hydrochloride	Cycle 2 300mg netupitant/0.5mg palonosetron hydrochloride	Cycle 3 300mg netupitant/0.5mg palonosetron hydrochloride	Cycle 4 300mg netupitant/0.5mg palonosetron hydrochloride
Total Functional Living Index-Emesis (FLIE) Score at Cycle 1	109.2 score on a scale Standard Deviation 17.7	—	—	—

SECONDARY outcome

Timeframe: Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days

Population: mITT

No emetic episode and no use of rescue medication in the overall period (0-120h/Day 1-5)

Outcome measures

Outcome measures
Measure	Treatment n=196 Participants 300mg netupitant/0.5mg palonosetron hydrochloride	Cycle 2 n=184 Participants 300mg netupitant/0.5mg palonosetron hydrochloride	Cycle 3 n=175 Participants 300mg netupitant/0.5mg palonosetron hydrochloride	Cycle 4 n=151 Participants 300mg netupitant/0.5mg palonosetron hydrochloride
Complete Response Missing Data	16 Participants	9 Participants	9 Participants	6 Participants
Complete Response Complete Response: Yes	84 Participants	97 Participants	104 Participants	101 Participants
Complete Response Complete Response: No	96 Participants	78 Participants	62 Participants	44 Participants

SECONDARY outcome

Timeframe: Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days

Population: mITT

Question 1 of the daily evaluation of the Patient Diary ("How much nausea did you experience on average during the last 24 hours?"). Data was collected on a visual analogue scale. Scale ranges from 0 mm ("no nausea") to 100 mm ("always severe nausea").

Outcome measures

Outcome measures
Measure	Treatment n=181 Participants 300mg netupitant/0.5mg palonosetron hydrochloride	Cycle 2 n=179 Participants 300mg netupitant/0.5mg palonosetron hydrochloride	Cycle 3 n=170 Participants 300mg netupitant/0.5mg palonosetron hydrochloride	Cycle 4 n=142 Participants 300mg netupitant/0.5mg palonosetron hydrochloride
Severity of Nausea on Day 5 (Change From Day 1)	-7.1 mm Standard Deviation 23.8	-3.3 mm Standard Deviation 21.6	-1.4 mm Standard Deviation 15.4	-1.5 mm Standard Deviation 10.7

Adverse Events

Treatment

Serious events: 39 serious events

Other events: 178 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=197 participants at risk 300mg netupitant/0.5mg palonosetron hydrochloride
Blood and lymphatic system disorders Febrile Neutropenia	4.1% 8/197 • Number of events 10 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Blood and lymphatic system disorders Neutropenia	1.0% 2/197 • Number of events 2 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Blood and lymphatic system disorders Thrombocytopenia	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Respiratory, thoracic and mediastinal disorders Pneumonia	3.6% 7/197 • Number of events 7 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Respiratory, thoracic and mediastinal disorders Metapneumovirus Infection	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Respiratory, thoracic and mediastinal disorders pneumothorax	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Respiratory, thoracic and mediastinal disorders Upper respiratory Tract Infection	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Gastrointestinal disorders Diarrhoea	1.0% 2/197 • Number of events 2 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Gastrointestinal disorders Nausea	1.0% 2/197 • Number of events 2 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Gastrointestinal disorders Anal Ulcer	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Gastrointestinal disorders Diverticular Perforation	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Gastrointestinal disorders Diverticulitis	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Gastrointestinal disorders Pancreatitis	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
General disorders Disease Progression	1.0% 2/197 • Number of events 2 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
General disorders Pyrexia	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
General disorders Sudden Death	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Vascular disorders Hypotension	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Vascular disorders Lower Gastrointestinal Haemorrhage	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Vascular disorders Septic Shock	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Vascular disorders Thrombosis	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Cardiac disorders Atrial Fibrillation	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Cardiac disorders Cardiac Arrest	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Cardiac disorders Cardiac Failure	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Cardiac disorders Supraventricular Tachycardia	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Infections and infestations Device Related Infection	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Infections and infestations Escherichia Bacteraemia	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Infections and infestations Sepsis	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Psychiatric disorders Hallucination, Visual	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Psychiatric disorders Panic Attack	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Renal and urinary disorders Eosinophilic Cystitis	0.51% 1/197 • Number of events 1 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.

Other adverse events

Other adverse events
Measure	Treatment n=197 participants at risk 300mg netupitant/0.5mg palonosetron hydrochloride
General disorders Fatigue	45.2% 89/197 • Number of events 122 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
General disorders Asthenia	7.6% 15/197 • Number of events 17 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
General disorders Decreased Appetite	6.6% 13/197 • Number of events 13 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Gastrointestinal disorders Constipation	29.4% 58/197 • Number of events 83 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Gastrointestinal disorders Diarrhoea	17.8% 35/197 • Number of events 42 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Gastrointestinal disorders Dyspepsia	17.3% 34/197 • Number of events 41 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Gastrointestinal disorders Nausea	13.7% 27/197 • Number of events 32 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Gastrointestinal disorders Abdominal Pain	5.6% 11/197 • Number of events 11 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Nervous system disorders Headache	14.7% 29/197 • Number of events 38 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Nervous system disorders Dysgeusia	7.1% 14/197 • Number of events 15 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.1% 14/197 • Number of events 14 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Respiratory, thoracic and mediastinal disorders Cough	6.6% 13/197 • Number of events 13 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Respiratory, thoracic and mediastinal disorders Pneumonia	5.1% 10/197 • Number of events 10 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Skin and subcutaneous tissue disorders Alopecia	23.4% 46/197 • Number of events 46 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Musculoskeletal and connective tissue disorders Pain in Extremity	5.6% 11/197 • Number of events 19 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Blood and lymphatic system disorders Neutropenia	8.1% 16/197 • Number of events 20 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
Psychiatric disorders Insomnia	5.6% 11/197 • Number of events 14 • The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.

Additional Information

Graeme Donnelly

Purdue Pharma (Canada)

Phone: 905.837-6498

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60