Trial Outcomes & Findings for A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC (NCT NCT02106494)

NCT ID: NCT02106494

Last Updated: 2016-12-28

Results Overview

Percentage of Participants with no emesis and no rescue medication in patients receiving HEC in the delayed phase (24 to 120 hours) of CINV.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 942 participants
• Primary outcome timeframe: 24 - 120 Hours
• Results posted on: 2016-12-28

Participant Flow

Patients receiving highly emetogenic chemotherapy were stratified by cisplatin and randomized 1:1 to one of two treatment arms

Participant milestones

Measure	APF530 + Fosaprepitant + Dexamethasone Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID	Ondansetron + Fosaprepitant + Dexamethasone Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID
Overall Study STARTED	471	471
Overall Study Safety Population	456	459
Overall Study Efficacy Population	450	452
Overall Study COMPLETED	445	446
Overall Study NOT COMPLETED	26	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC

Baseline characteristics by cohort

Measure	APF530 + Fosaprepitant + Dexamethasone n=450 Participants Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID	Ondansetron + Fosaprepitant + Dexamethasone n=452 Participants Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID	Total n=902 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	333 Participants n=5 Participants	334 Participants n=7 Participants	667 Participants n=5 Participants
Age, Categorical >=65 years	117 Participants n=5 Participants	118 Participants n=7 Participants	235 Participants n=5 Participants
Age, Continuous	55.7 years STANDARD_DEVIATION 11.74 • n=5 Participants	55.6 years STANDARD_DEVIATION 11.94 • n=7 Participants	55.65 years STANDARD_DEVIATION 11.84 • n=5 Participants
Gender Female	358 Participants n=5 Participants	373 Participants n=7 Participants	731 Participants n=5 Participants
Gender Male	92 Participants n=5 Participants	79 Participants n=7 Participants	171 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 - 120 Hours

Population: Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.

Percentage of Participants with no emesis and no rescue medication in patients receiving HEC in the delayed phase (24 to 120 hours) of CINV.

Outcome measures

Measure	APF530 + Fosaprepitant + Dexamethasone n=450 Participants Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID	Ondansetron + Fosaprepitant + Dexamethasone n=452 Participants Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID
Delayed Phase Complete Response (CR) Rate	64.7 percentage of participants	56.6 percentage of participants

SECONDARY outcome

Timeframe: 0 - 120 Hours

Population: Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.

To determine the effect of APF530 on complete response rates in the overall phase (0 to 120 hours) of CINV.

Outcome measures

Measure	APF530 + Fosaprepitant + Dexamethasone n=450 Participants Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID	Ondansetron + Fosaprepitant + Dexamethasone n=452 Participants Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID
Overall Complete Response Rate	58.4 percentage of participants	52.9 percentage of participants

SECONDARY outcome

Timeframe: 24 - 120 Hours

Population: Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.

To determine the effect of APF530 on complete control rates defined as no more than mild nausea, no emetic episodes [vomiting or retching], and no use of rescue medications in the delayed phase (24 to 120 hours) of CINV.

Outcome measures

Measure	APF530 + Fosaprepitant + Dexamethasone n=450 Participants Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID	Ondansetron + Fosaprepitant + Dexamethasone n=452 Participants Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID
Delayed Complete Control (CC) Rate	60.7 percentage of participants	53.1 percentage of participants

SECONDARY outcome

Timeframe: 0 - 120 Hours

Population: Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.

To determine the effect of APF530 on complete control rates defined as no more than mild nausea, no emetic episodes [vomiting or retching], and no use of rescue medications in the overall phase (0 to 120 hours) of CINV.

Outcome measures

Measure	APF530 + Fosaprepitant + Dexamethasone n=450 Participants Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID	Ondansetron + Fosaprepitant + Dexamethasone n=452 Participants Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID
Overall Complete Control Rate	54.7 percentage of participants	49.6 percentage of participants

SECONDARY outcome

Timeframe: 0 - 120 Hours

Population: Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.

To determine the effect of APF530 on the rate of no emetic episodes (vomiting or retching) in the overall phase (0 to 120 hours) of CINV.

Outcome measures

Measure	APF530 + Fosaprepitant + Dexamethasone n=450 Participants Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID	Ondansetron + Fosaprepitant + Dexamethasone n=452 Participants Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID
Rate of No Emetic Episodes	82.2 percentage of participants	79.2 percentage of participants

Adverse Events

APF530 + Fosaprepitant + Dexamethasone

Serious events: 42 serious events

Other events: 411 other events

Deaths: 0 deaths

Ondansetron + Fosaprepitant + Dexamethasone

Serious events: 28 serious events

Other events: 407 other events

Deaths: 0 deaths

Serious adverse events

Measure	APF530 + Fosaprepitant + Dexamethasone n=456 participants at risk Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID	Ondansetron + Fosaprepitant + Dexamethasone n=459 participants at risk Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID
Blood and lymphatic system disorders Febria Neutropenia	2.0% 9/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	1.3% 6/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Blood and lymphatic system disorders Pancytopenia	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Cardiac disorders Atrial Fibrillation	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Cardiac disorders Cardio-respiratory arrest	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Gastrointestinal disorders Abdominal Pain	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.22% 1/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Gastrointestinal disorders Constipation	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Gastrointestinal disorders Diarrhoea	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Gastrointestinal disorders Diverticular Perforation	0.00% 0/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.22% 1/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Gastrointestinal disorders Faecaloma	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Gastrointestinal disorders Mouth Haemmorrhage	0.00% 0/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.22% 1/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Gastrointestinal disorders Nausea	0.44% 2/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.65% 3/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Gastrointestinal disorders Pancreatitis	0.44% 2/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Gastrointestinal disorders Pancreatitis Acute	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Gastrointestinal disorders Vomiting	0.66% 3/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.65% 3/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
General disorders Pyrexia	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Hepatobiliary disorders Cholecystitis Acute	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Infections and infestations Breast Abscess	0.00% 0/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.22% 1/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Infections and infestations Breast Cellulitis	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Infections and infestations Device related infection	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Infections and infestations Device related sepsis	0.00% 0/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.22% 1/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Infections and infestations Folliculitis	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Infections and infestations Injection Site Infection	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Infections and infestations Neutropenic Sepsis	0.00% 0/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.22% 1/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Infections and infestations Peritonitis	0.00% 0/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.22% 1/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Infections and infestations Pneumonia	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.44% 2/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Infections and infestations Post procedural cellulitis	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Infections and infestations Sepsis	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Infections and infestations Wound Infection	0.00% 0/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.22% 1/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Injury, poisoning and procedural complications Chemical Peritonitis	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Injury, poisoning and procedural complications Traumatic Intracranial Hemorrhage	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Metabolism and nutrition disorders Dehydration	0.44% 2/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.65% 3/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Musculoskeletal and connective tissue disorders Muscular weakness	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.44% 2/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.22% 1/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Nervous system disorders Cerebrovascular accident	0.44% 2/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.22% 1/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Nervous system disorders Convulsion	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Nervous system disorders Presyncope	0.00% 0/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.22% 1/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Nervous system disorders Syncope	0.00% 0/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.22% 1/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Psychiatric disorders Mental Status Changes	0.00% 0/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.22% 1/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Renal and urinary disorders Renal Failure Acute	0.44% 2/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.65% 3/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Reproductive system and breast disorders Breast Pain	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary	0.00% 0/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.22% 1/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.44% 2/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.22% 1/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	0.00% 0/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.

Other adverse events

Measure	APF530 + Fosaprepitant + Dexamethasone n=456 participants at risk Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID	Ondansetron + Fosaprepitant + Dexamethasone n=459 participants at risk Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV Day 2 - Dexamethasone 8 mg PO QD Days 3 and 4 - Dexamethasone 8 mg PO BID
Nervous system disorders Headache	12.3% 56/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	17.9% 82/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Blood and lymphatic system disorders Neutropenia	5.7% 26/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	6.5% 30/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Gastrointestinal disorders Constipation	21.7% 99/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	15.3% 70/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Gastrointestinal disorders Diarrhea	8.6% 39/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	7.6% 35/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Gastrointestinal disorders Dyspepsia	5.9% 27/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	7.0% 32/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Gastrointestinal disorders Nausea	16.4% 75/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	15.5% 71/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
General disorders Fatigue	20.8% 95/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	23.7% 109/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
General disorders Injection site bruising	41.9% 191/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	33.6% 154/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
General disorders Injection site erythema	16.9% 77/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	27.7% 127/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
General disorders Injection site haemorrhage	5.0% 23/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	7.8% 36/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
General disorders Injection site nodule	18.0% 82/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	9.8% 45/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
General disorders Injection site pain	30.9% 141/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	35.5% 163/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
General disorders Injection site swelling	9.9% 45/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	11.5% 53/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Metabolism and nutrition disorders Decreased Appetite	5.3% 24/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	5.0% 23/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Nervous system disorders Dizziness	5.5% 25/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	5.4% 25/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.
Psychiatric disorders Insomnia	4.6% 21/456 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.	6.3% 29/459 • The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration. Events other than injection site reactions were collected by non-systematic assessment. Injection site reactions were also collected via patient diaries.

Additional Information

Robert Geller, M.D.

Heron Therapeutics

Phone: 650-366-2626

Email: rgeller@herontx.com

Results disclosure agreements

• Principal investigator is a sponsor employee A period of 60 working days for presentational material and abstracts and 90 days for manuscripts is permitted for the sponsor's review. The sponsor can request modifications of any manuscript or other materials to be published or presented. The sponsor can also request additional time to obtain additional patent protection or take such other measures to establish and preserve its intellectual property and proprietary rights before publishing information from this trial.
• Publication restrictions are in place

Restriction type: OTHER