Trial Outcomes & Findings for Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017) (NCT NCT00619359)

NCT ID: NCT00619359

Last Updated: 2017-03-21

Results Overview

The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2322 participants

Primary outcome timeframe

Overall (in the 120 hours following initiation of cisplatin chemotherapy).

Results posted on

2017-03-21

Participant Flow

Patients were recruited from 149 medical centers worldwide. The recruitment period was from 12 Feb 08 through 8 Jun 09.

Cisplatin-naïve patients scheduled to receive cisplatin chemotherapy at a dose of 70 mg/m2 or higher for a documented solid malignancy were screened up to 30 days prior to initiation of chemotherapy. Screening included a complete medical history and physical exam. Informed consent was obtained for patients who agreed to participate in the study.

Participant milestones

Participant milestones
Measure	Fosaprepitant Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.	Aprepitant Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
Overall Study STARTED	1147	1175
Overall Study COMPLETED	1080	1094
Overall Study NOT COMPLETED	67	81

Reasons for withdrawal

Reasons for withdrawal
Measure	Fosaprepitant Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.	Aprepitant Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
Overall Study Adverse Event	32	36
Overall Study Lost to Follow-up	12	16
Overall Study Physician Decision	0	7
Overall Study Protocol Violation	1	1
Overall Study Withdrawal by Subject	19	20
Overall Study Progressive Disease	3	1

Baseline Characteristics

Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fosaprepitant n=1147 Participants Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.	Aprepitant n=1175 Participants Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.	Total n=2322 Participants Total of all reporting groups
Age, Continuous	55.2 years n=5 Participants	55.9 years n=7 Participants	55.6 years n=5 Participants
Sex: Female, Male Female	425 Participants n=5 Participants	427 Participants n=7 Participants	852 Participants n=5 Participants
Sex: Female, Male Male	722 Participants n=5 Participants	748 Participants n=7 Participants	1470 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	32 participants n=5 Participants	33 participants n=7 Participants	65 participants n=5 Participants
Race/Ethnicity, Customized Asian	296 participants n=5 Participants	306 participants n=7 Participants	602 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	21 participants n=5 Participants	22 participants n=7 Participants	43 participants n=5 Participants
Race/Ethnicity, Customized Multi-Racial	149 participants n=5 Participants	157 participants n=7 Participants	306 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized White	648 participants n=5 Participants	655 participants n=7 Participants	1303 participants n=5 Participants
History of Motion Sickness Yes	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
History of Motion Sickness No	1143 Participants n=5 Participants	1166 Participants n=7 Participants	2309 Participants n=5 Participants
History of Motion Sickness No Data - Assessment Not Completed	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
History of Vomiting with Pregnancy Yes	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
History of Vomiting with Pregnancy No	420 Participants n=5 Participants	421 Participants n=7 Participants	841 Participants n=5 Participants
History of Vomiting with Pregnancy Female Patients with No Data - No Assessment	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
History of Vomiting with Pregnancy Not Applicable - Male Patients	722 Participants n=5 Participants	748 Participants n=7 Participants	1470 Participants n=5 Participants

PRIMARY outcome

Timeframe: Overall (in the 120 hours following initiation of cisplatin chemotherapy).

Population: FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment.

The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.

Outcome measures

Outcome measures
Measure	Fosaprepitant n=1106 Participants Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.	Aprepitant n=1134 Participants Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).	795 Participants	820 Participants

SECONDARY outcome

Timeframe: Delayed phase (25 to 120 hours following initiation of cisplatin).

The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 25 to 120 hours following initiation of cisplatin chemotherapy.

Outcome measures

Outcome measures
Measure	Fosaprepitant n=1106 Participants Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.	Aprepitant n=1133 Participants Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).	822 Participants	841 Participants

SECONDARY outcome

Timeframe: Overall (the 120 hours following initiation of cisplatin chemotherapy)

The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy.

Outcome measures

Outcome measures
Measure	Fosaprepitant n=1106 Participants Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.	Aprepitant n=1132 Participants Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)	806 Participants	844 Participants

Adverse Events

Fosaprepitant

Serious events: 148 serious events

Other events: 636 other events

Deaths: 0 deaths

Aprepitant

Serious events: 157 serious events

Other events: 679 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Fosaprepitant n=1143 participants at risk Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4. 4 patients from the fosaprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables.	Aprepitant n=1169 participants at risk Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4. 6 patients from the aprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.09% 1/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Vascular disorders Arterial occlusive disease	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Vascular disorders Arteriosclerosis	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Vascular disorders Arterial thrombosis	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Blood and lymphatic system disorders Anaemia	0.26% 3/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.26% 3/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Blood and lymphatic system disorders Febrile neutropenia	1.6% 18/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	2.3% 27/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Blood and lymphatic system disorders Leukopenia	0.35% 4/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.17% 2/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Blood and lymphatic system disorders Neutropenia	1.5% 17/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	1.1% 13/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Blood and lymphatic system disorders Pancytopenia	0.26% 3/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Blood and lymphatic system disorders Thrombocytopenia	0.17% 2/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.17% 2/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Cardiac disorders Atrial fibrillation	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Cardiac disorders Cardiac arrest	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.17% 2/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Cardiac disorders Cardio-respiratory arrest	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Cardiac disorders Cardiopulmonary failure	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Cardiac disorders Myocardial infarction	0.00% 0/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.09% 1/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Cardiac disorders Palpitations	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Cardiac disorders Supraventricular tachycardia	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Ear and labyrinth disorders Vertigo	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Eye disorders Conjunctival haemorrhage	0.00% 0/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.09% 1/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Eye disorders Diplopia	0.00% 0/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.09% 1/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Abdominal pain	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.34% 4/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.09% 1/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Constipation	0.17% 2/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.09% 1/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Diarrhoea	0.26% 3/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.68% 8/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Duodenal ulcer perforation	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Dysphagia	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Enteritis	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Faecaloma	0.00% 0/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.09% 1/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Gastric perforation	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.09% 1/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.09% 1/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Gastritis	0.00% 0/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.09% 1/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Gastritis erosive	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.17% 2/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Gastrointestinal necrosis	0.00% 0/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.09% 1/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Haematemesis	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.09% 1/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Haematochezia	0.09% 1/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.00% 0/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.09% 1/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.17% 2/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Melaena	0.00% 0/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.09% 1/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.

Other adverse events
Measure	Fosaprepitant n=1143 participants at risk Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4. 4 patients from the fosaprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables.	Aprepitant n=1169 participants at risk Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4. 6 patients from the aprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables.
Blood and lymphatic system disorders Anaemia	1.5% 17/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.60% 7/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Blood and lymphatic system disorders Leukopenia	1.2% 14/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	1.4% 16/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Blood and lymphatic system disorders Neutropenia	2.4% 28/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	2.1% 25/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Blood and lymphatic system disorders Thrombocytopenia	1.5% 17/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	1.2% 14/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Ear and labyrinth disorders Tinnitus	1.7% 19/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.86% 10/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Abdominal pain	3.0% 34/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	3.0% 35/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Abdominal pain upper	4.0% 46/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	2.5% 29/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Constipation	10.4% 119/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	9.5% 111/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Diarrhoea	7.5% 86/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	8.1% 95/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Dyspepsia	4.4% 50/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	3.3% 38/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Gastritis	1.0% 12/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.77% 9/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Nausea	5.6% 64/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	6.7% 78/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Stomatitis	1.7% 20/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	1.5% 18/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Gastrointestinal disorders Vomiting	5.4% 62/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	5.0% 58/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
General disorders Asthenia	8.2% 94/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	11.0% 129/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
General disorders Chest pain	1.3% 15/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	1.5% 18/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
General disorders Fatigue	4.6% 53/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	4.8% 56/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
General disorders Infusion site pain	1.4% 16/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.09% 1/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
General disorders Mucosal inflammation	1.9% 22/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	2.7% 32/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
General disorders Pain	0.96% 11/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.86% 10/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
General disorders Pyrexia	1.9% 22/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	2.0% 23/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Injury, poisoning and procedural complications Accidental overdose	0.96% 11/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	1.1% 13/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Investigations Alanine aminotransferase increased	1.3% 15/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	1.5% 17/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Investigations Blood creatinine increased	1.2% 14/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	1.0% 12/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Metabolism and nutrition disorders Anorexia	6.5% 74/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	8.6% 101/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Metabolism and nutrition disorders Dehydration	1.7% 20/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	2.7% 32/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Metabolism and nutrition disorders Hypokalaemia	1.1% 13/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.86% 10/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Metabolism and nutrition disorders Hyponatraemia	0.87% 10/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	1.1% 13/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Musculoskeletal and connective tissue disorders Myalgia	1.4% 16/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	1.5% 17/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Musculoskeletal and connective tissue disorders Pain in extremity	1.6% 18/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	1.4% 16/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Nervous system disorders Dizziness	3.3% 38/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	2.9% 34/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Nervous system disorders Dysgeusia	1.2% 14/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	1.2% 14/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Nervous system disorders Headache	4.0% 46/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	4.1% 48/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Psychiatric disorders Insomnia	1.2% 14/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	1.6% 19/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Respiratory, thoracic and mediastinal disorders Cough	2.3% 26/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	1.9% 22/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.4% 16/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	1.3% 15/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Respiratory, thoracic and mediastinal disorders Hiccups	5.5% 63/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	6.3% 74/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Skin and subcutaneous tissue disorders Alopecia	1.0% 12/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	1.4% 16/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Skin and subcutaneous tissue disorders Erythema	1.1% 13/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.34% 4/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Vascular disorders Hypertension	1.5% 17/1143 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.	0.51% 6/1169 • AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug. Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.