Trial Outcomes & Findings for APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer (NCT NCT00343460)
NCT ID: NCT00343460
Last Updated: 2017-02-23
Results Overview
Complete Response is defined as no emetic episodes and no use of rescue medications
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1428 participants
Primary outcome timeframe
0-24 Hours
Results posted on
2017-02-23
Participant Flow
Participant milestones
| Measure |
APF530 5 mg
APF530 5 mg - Safety Population
|
APF530 10 mg
APF530 10 mg - Safety Population
|
Aloxi 0.25 mg
Aloxi 0.25 mg - Safety Population
|
|---|---|---|---|
|
Cycle 1
STARTED
|
475
|
481
|
472
|
|
Cycle 1
COMPLETED
|
453
|
459
|
454
|
|
Cycle 1
NOT COMPLETED
|
22
|
22
|
18
|
|
Cycle 2 - 4
STARTED
|
584
|
565
|
0
|
|
Cycle 2 - 4
COMPLETED
|
528
|
515
|
0
|
|
Cycle 2 - 4
NOT COMPLETED
|
56
|
50
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
Baseline characteristics by cohort
| Measure |
Cycle 1 APF530 5 mg - Moderately
n=214 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 10 mg - Moderately
n=212 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 Aloxi 0.25 mg - Moderately
n=208 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 5 mg - Highly
n=229 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 APF530 10 mg - Highly
n=240 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 Aloxi 0.25 Highly
n=238 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Total
n=1341 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 12.80 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 12.79 • n=7 Participants
|
57.3 years
STANDARD_DEVIATION 12.36 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 13.35 • n=4 Participants
|
56.8 years
STANDARD_DEVIATION 13.20 • n=21 Participants
|
58.1 years
STANDARD_DEVIATION 13.74 • n=8 Participants
|
56.62 years
STANDARD_DEVIATION 13.04 • n=8 Participants
|
|
Sex: Female, Male
Female
|
189 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
152 Participants
n=21 Participants
|
158 Participants
n=8 Participants
|
1006 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
80 Participants
n=8 Participants
|
335 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 0-24 HoursPopulation: Cycle 1 - Modified Intent-to-Treat Population
Complete Response is defined as no emetic episodes and no use of rescue medications
Outcome measures
| Measure |
Cycle 1 APF530 5 mg - Moderately
n=214 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 10 mg - Moderately
n=212 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 Aloxi 0.25 mg - Moderately
n=208 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 5 mg - Highly
n=229 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 APF530 10 mg - Highly
n=240 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 Aloxi 0.25 Highly
n=238 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
|---|---|---|---|---|---|---|
|
Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1
|
160 participants
|
163 participants
|
156 participants
|
178 participants
|
195 participants
|
192 participants
|
PRIMARY outcome
Timeframe: 24-120 HoursPopulation: Cycle 1 - Modified Intent-to-Treat Population
Complete Response is defined as no emetic episodes and no use of rescue medications
Outcome measures
| Measure |
Cycle 1 APF530 5 mg - Moderately
n=214 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 10 mg - Moderately
n=212 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 Aloxi 0.25 mg - Moderately
n=208 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 5 mg - Highly
n=229 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 APF530 10 mg - Highly
n=240 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 Aloxi 0.25 Highly
n=238 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
|---|---|---|---|---|---|---|
|
Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1
|
110 participants
|
125 participants
|
120 participants
|
148 participants
|
164 participants
|
158 participants
|
SECONDARY outcome
Timeframe: 0-120 HoursPopulation: Cycle 1 - Modified Intent-to-Treat Population
Complete control is defined as complete response with no more than mild nausea.
Outcome measures
| Measure |
Cycle 1 APF530 5 mg - Moderately
n=214 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 10 mg - Moderately
n=212 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 Aloxi 0.25 mg - Moderately
n=208 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 5 mg - Highly
n=229 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 APF530 10 mg - Highly
n=240 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 Aloxi 0.25 Highly
n=238 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
|---|---|---|---|---|---|---|
|
Proportion of Patients With Complete Control During the Acute Phase (0-24 Hours), Delayed-onset Phase (24-120 Hours), and During Chemotherapy Course 1
CC during acute Phase
|
154 participants
|
152 participants
|
147 participants
|
170 participants
|
183 participants
|
184 participants
|
|
Proportion of Patients With Complete Control During the Acute Phase (0-24 Hours), Delayed-onset Phase (24-120 Hours), and During Chemotherapy Course 1
CC during the delayed-onset phase
|
100 participants
|
115 participants
|
107 participants
|
138 participants
|
150 participants
|
147 participants
|
|
Proportion of Patients With Complete Control During the Acute Phase (0-24 Hours), Delayed-onset Phase (24-120 Hours), and During Chemotherapy Course 1
CC during the overall risk period
|
93 participants
|
107 participants
|
99 participants
|
127 participants
|
138 participants
|
136 participants
|
SECONDARY outcome
Timeframe: 0-120 HoursPopulation: Cycle 1 - Modified Intent-to-Treat Population
TR during acute phase is defined as Complete Response with no nausea during 0 to 24 hours following the administration of chemotherapy in Cycle 1. TR during delayed-onset phase is defined as Complete Response with no nausea during \>24 to 120 hours following the administration of chemotherapy in Cycle 1. TR during overall risk period is defined as Complete Response with no nausea during 0 to 120 hours following the administration of chemotherapy in Cycle 1.
Outcome measures
| Measure |
Cycle 1 APF530 5 mg - Moderately
n=214 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 10 mg - Moderately
n=212 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 Aloxi 0.25 mg - Moderately
n=208 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 5 mg - Highly
n=229 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 APF530 10 mg - Highly
n=240 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 Aloxi 0.25 Highly
n=238 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
|---|---|---|---|---|---|---|
|
Proportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 1
TR during acute phase
|
135 participants
|
121 participants
|
113 participants
|
141 participants
|
146 participants
|
158 participants
|
|
Proportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 1
TR during the delayed-onset phase
|
76 participants
|
89 participants
|
73 participants
|
115 participants
|
113 participants
|
122 participants
|
|
Proportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 1
TR during the overall risk period
|
68 participants
|
79 participants
|
65 participants
|
103 participants
|
101 participants
|
117 participants
|
SECONDARY outcome
Timeframe: Days 1-5Population: Cycle 1 - Modified Intent-to-Treat Population
Number of Emetic Episodes - days 1-5
Outcome measures
| Measure |
Cycle 1 APF530 5 mg - Moderately
n=208 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 10 mg - Moderately
n=208 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 Aloxi 0.25 mg - Moderately
n=205 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 5 mg - Highly
n=217 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 APF530 10 mg - Highly
n=236 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 Aloxi 0.25 Highly
n=222 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
|---|---|---|---|---|---|---|
|
Number of Emetic Episodes
|
3.4 Number of Emetic Episodes
Standard Deviation 8.03
|
3.1 Number of Emetic Episodes
Standard Deviation 9.35
|
2.1 Number of Emetic Episodes
Standard Deviation 5.12
|
2.3 Number of Emetic Episodes
Standard Deviation 6.69
|
2.4 Number of Emetic Episodes
Standard Deviation 7.87
|
2.5 Number of Emetic Episodes
Standard Deviation 7.15
|
SECONDARY outcome
Timeframe: 0-120 HoursPopulation: Proportions of subjects event free in Cycle 1 - Modified Intent-to-Treat Population
Proportions of subjects event free at 24, 48, 72, 96, and 120 hours after chemotherapy administration
Outcome measures
| Measure |
Cycle 1 APF530 5 mg - Moderately
n=214 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 10 mg - Moderately
n=211 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 Aloxi 0.25 mg - Moderately
n=208 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 5 mg - Highly
n=228 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 APF530 10 mg - Highly
n=238 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 Aloxi 0.25 Highly
n=238 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
|---|---|---|---|---|---|---|
|
Time to First Treatment Failure
72 Hours
|
0.533 Proportion of subjects event free
|
0.564 Proportion of subjects event free
|
0.567 Proportion of subjects event free
|
0.649 Proportion of subjects event free
|
0.685 Proportion of subjects event free
|
0.672 Proportion of subjects event free
|
|
Time to First Treatment Failure
24 Hours
|
0.738 Proportion of subjects event free
|
0.763 Proportion of subjects event free
|
0.755 Proportion of subjects event free
|
0.781 Proportion of subjects event free
|
0.811 Proportion of subjects event free
|
0.803 Proportion of subjects event free
|
|
Time to First Treatment Failure
48 Hours
|
0.636 Proportion of subjects event free
|
0.659 Proportion of subjects event free
|
0.635 Proportion of subjects event free
|
0.706 Proportion of subjects event free
|
0.723 Proportion of subjects event free
|
0.714 Proportion of subjects event free
|
|
Time to First Treatment Failure
96 Hours
|
0.485 Proportion of subjects event free
|
0.550 Proportion of subjects event free
|
0.534 Proportion of subjects event free
|
0.618 Proportion of subjects event free
|
0.668 Proportion of subjects event free
|
0.634 Proportion of subjects event free
|
|
Time to First Treatment Failure
120 Hours
|
0.485 Proportion of subjects event free
|
0.540 Proportion of subjects event free
|
0.529 Proportion of subjects event free
|
0.600 Proportion of subjects event free
|
0.647 Proportion of subjects event free
|
0.620 Proportion of subjects event free
|
SECONDARY outcome
Timeframe: 0-120 HoursPopulation: Cycle 1 - Modified Intent-to-Treat Population
Outcome measures
| Measure |
Cycle 1 APF530 5 mg - Moderately
n=214 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 10 mg - Moderately
n=212 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 Aloxi 0.25 mg - Moderately
n=208 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 5 mg - Highly
n=229 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 APF530 10 mg - Highly
n=240 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 Aloxi 0.25 Highly
n=238 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
|---|---|---|---|---|---|---|
|
First and Overall Use of Rescue Medication
Used Rescue Medication, 0-24 hours
|
42 participants
|
37 participants
|
41 participants
|
35 participants
|
23 participants
|
25 participants
|
|
First and Overall Use of Rescue Medication
Used Rescue Medication, 24-120 hours
|
83 participants
|
69 participants
|
63 participants
|
60 participants
|
42 participants
|
42 participants
|
|
First and Overall Use of Rescue Medication
Used Rescue Medication, 0-120 hours
|
89 participants
|
76 participants
|
72 participants
|
71 participants
|
45 participants
|
49 participants
|
SECONDARY outcome
Timeframe: 0-120 HoursPopulation: Severity of Nausea - Cycle 1 - Modified Intent-to-Treat Population
Maximum severity of nausea, days 1-5
Outcome measures
| Measure |
Cycle 1 APF530 5 mg - Moderately
n=212 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 10 mg - Moderately
n=210 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 Aloxi 0.25 mg - Moderately
n=204 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 5 mg - Highly
n=219 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 APF530 10 mg - Highly
n=235 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 Aloxi 0.25 Highly
n=232 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
|---|---|---|---|---|---|---|
|
Severity of Nausea Daily and During Chemotherapy Course 1 (0-120 Hours)
None
|
78 participants
|
85 participants
|
66 participants
|
105 participants
|
102 participants
|
121 participants
|
|
Severity of Nausea Daily and During Chemotherapy Course 1 (0-120 Hours)
Mild
|
45 participants
|
53 participants
|
68 participants
|
53 participants
|
68 participants
|
53 participants
|
|
Severity of Nausea Daily and During Chemotherapy Course 1 (0-120 Hours)
Moderate
|
59 participants
|
40 participants
|
46 participants
|
48 participants
|
37 participants
|
39 participants
|
|
Severity of Nausea Daily and During Chemotherapy Course 1 (0-120 Hours)
Severe
|
30 participants
|
32 participants
|
24 participants
|
13 participants
|
28 participants
|
19 participants
|
SECONDARY outcome
Timeframe: 0-120 HoursPopulation: Number of subjects in the Modified Intent-to-Treat Population with overall CR (0-120 hrs) in all cycles
Sustainability of Overall Complete Response (CR 0-120 hrs) Over Two, Three, and Four Cycles Complete Response is defined as no emetic episodes and no use of rescue medications
Outcome measures
| Measure |
Cycle 1 APF530 5 mg - Moderately
n=91 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 10 mg - Moderately
n=92 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 Aloxi 0.25 mg - Moderately
n=106 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 5 mg - Highly
n=95 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 APF530 10 mg - Highly
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 Aloxi 0.25 Highly
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
|---|---|---|---|---|---|---|
|
Sustainability of Antiemetic Effect of APF530 Over Multiple Chemotherapy Courses
|
34 participants with overall CR
|
35 participants with overall CR
|
56 participants with overall CR
|
52 participants with overall CR
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Cycle 1 - Modified Intent-to-Treat Population (All Languages Except Punjabi)
Functional Living Index
Outcome measures
| Measure |
Cycle 1 APF530 5 mg - Moderately
n=208 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 10 mg - Moderately
n=210 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 Aloxi 0.25 mg - Moderately
n=204 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 5 mg - Highly
n=223 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 APF530 10 mg - Highly
n=228 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 Aloxi 0.25 Highly
n=231 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
|---|---|---|---|---|---|---|
|
Quality of Life and the Impact of Nausea and Vomiting on Day 5
No nausea impact on daily life
|
112 participants
|
127 participants
|
120 participants
|
142 participants
|
142 participants
|
159 participants
|
|
Quality of Life and the Impact of Nausea and Vomiting on Day 5
No vomiting impact on daily life
|
157 participants
|
162 participants
|
160 participants
|
173 participants
|
182 participants
|
191 participants
|
SECONDARY outcome
Timeframe: 0- 24 HoursPopulation: Cycle 1 - Modified Intent-to-Treat Population
Subject who were very satisfied on Day 1
Outcome measures
| Measure |
Cycle 1 APF530 5 mg - Moderately
n=211 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 10 mg - Moderately
n=212 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 Aloxi 0.25 mg - Moderately
n=208 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately
|
Cycle 1 APF530 5 mg - Highly
n=229 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 APF530 10 mg - Highly
n=240 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
Cycle 1 Aloxi 0.25 Highly
n=238 Participants
Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly
|
|---|---|---|---|---|---|---|
|
Patient's Global Satisfaction With Antiemetic Therapy During Acute Phase and Chemotherapy Course 1
|
101 participants
|
113 participants
|
98 participants
|
128 participants
|
128 participants
|
135 participants
|
Adverse Events
Cycle 1 APF530 5 mg
Serious events: 42 serious events
Other events: 335 other events
Deaths: 0 deaths
Cycle 1 APF530 10 mg
Serious events: 36 serious events
Other events: 349 other events
Deaths: 0 deaths
Cycle 1 Aloxi 0.25 mg
Serious events: 27 serious events
Other events: 313 other events
Deaths: 0 deaths
Cycles 2-4 APF530 5 mg
Serious events: 61 serious events
Other events: 422 other events
Deaths: 0 deaths
Cycle 2-4 APF530 10 mg
Serious events: 73 serious events
Other events: 413 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cycle 1 APF530 5 mg
n=464 participants at risk
Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
|
Cycle 1 APF530 10 mg
n=468 participants at risk
Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
|
Cycle 1 Aloxi 0.25 mg
n=472 participants at risk
Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
|
Cycles 2-4 APF530 5 mg
n=528 participants at risk
Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population
|
Cycle 2-4 APF530 10 mg
n=515 participants at risk
Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.43%
2/464
|
0.00%
0/468
|
0.42%
2/472
|
1.1%
6/528
|
0.39%
2/515
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.43%
2/464
|
1.5%
7/468
|
0.64%
3/472
|
0.95%
5/528
|
1.6%
8/515
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.19%
1/515
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.43%
2/464
|
0.21%
1/468
|
0.42%
2/472
|
0.38%
2/528
|
1.2%
6/515
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.43%
2/464
|
0.43%
2/468
|
0.21%
1/472
|
0.38%
2/528
|
0.39%
2/515
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.65%
3/464
|
0.21%
1/468
|
0.00%
0/472
|
0.19%
1/528
|
0.58%
3/515
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Cardiac disorders
Atrial fibrillation
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.39%
2/515
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Cardiac disorders
Sudden Death
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Cardiac disorders
Ventricular tachycardia
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Ear and labyrinth disorders
Vertigo
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Endocrine disorders
Diabetes mellitus
|
0.22%
1/464
|
0.00%
0/468
|
0.21%
1/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Endocrine disorders
Hyperglycaemia
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
0.00%
0/528
|
0.39%
2/515
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
0.19%
1/528
|
0.39%
2/515
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Gastrointestinal disorders
Constipation
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Gastrointestinal disorders
Diarrhoea
|
0.43%
2/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.39%
2/515
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/464
|
0.43%
2/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.38%
2/528
|
0.39%
2/515
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/464
|
0.00%
0/468
|
0.21%
1/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Gastrointestinal disorders
Ileus
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Gastrointestinal disorders
Nausea
|
0.22%
1/464
|
0.64%
3/468
|
0.42%
2/472
|
0.57%
3/528
|
0.19%
1/515
|
|
Gastrointestinal disorders
Oesophageal carcinoma recurrent
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/464
|
0.00%
0/468
|
0.21%
1/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Gastrointestinal disorders
Vomiting
|
0.22%
1/464
|
0.85%
4/468
|
0.21%
1/472
|
0.19%
1/528
|
0.58%
3/515
|
|
General disorders
Asthenia
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
0.19%
1/528
|
0.19%
1/515
|
|
General disorders
Chest pain
|
0.22%
1/464
|
0.21%
1/468
|
0.21%
1/472
|
0.19%
1/528
|
0.39%
2/515
|
|
General disorders
Death
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
General disorders
Drug hypersensitivity
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.39%
2/515
|
|
General disorders
Fatigue
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
General disorders
Injection site haemorrhage
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
General disorders
Multi-organ failure
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
General disorders
Oedema peripheral
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
General disorders
Pain
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
General disorders
Pyrexia
|
0.22%
1/464
|
0.00%
0/468
|
0.21%
1/472
|
0.57%
3/528
|
0.19%
1/515
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Infections and infestations
Bronchitis chronic
|
0.00%
0/464
|
0.00%
0/468
|
0.21%
1/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/464
|
0.00%
0/468
|
0.21%
1/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Infections and infestations
Catheter related infection
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.39%
2/515
|
|
Infections and infestations
Cellulitis
|
0.22%
1/464
|
0.00%
0/468
|
0.21%
1/472
|
0.19%
1/528
|
0.19%
1/515
|
|
Infections and infestations
Clostridium difficile colitis
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Infections and infestations
Infection
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Infections and infestations
Pneumonia
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
1.3%
7/528
|
0.78%
4/515
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/464
|
0.21%
1/468
|
0.21%
1/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Infections and infestations
Sepsis
|
0.22%
1/464
|
0.21%
1/468
|
0.42%
2/472
|
0.76%
4/528
|
0.19%
1/515
|
|
Infections and infestations
Septic shock
|
0.00%
0/464
|
0.00%
0/468
|
0.21%
1/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/464
|
0.00%
0/468
|
0.21%
1/472
|
0.19%
1/528
|
0.39%
2/515
|
|
Infections and infestations
Urinary tract infection
|
0.22%
1/464
|
0.21%
1/468
|
0.00%
0/472
|
0.38%
2/528
|
0.19%
1/515
|
|
Infections and infestations
Wound infection
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Investigations
Prothrombin level abnormal
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Investigations
Weight decreased
|
0.00%
0/464
|
0.00%
0/468
|
0.21%
1/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Metabolism and nutrition disorders
Dehydration
|
0.22%
1/464
|
0.43%
2/468
|
0.42%
2/472
|
0.76%
4/528
|
1.2%
6/515
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.22%
1/464
|
0.00%
0/468
|
0.21%
1/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/464
|
0.00%
0/468
|
0.21%
1/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.39%
2/515
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/464
|
0.00%
0/468
|
0.21%
1/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Nervous system disorders
Convulsion
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Nervous system disorders
Headache
|
0.00%
0/464
|
0.00%
0/468
|
0.21%
1/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Nervous system disorders
Presyncope
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Nervous system disorders
Somnolence
|
0.00%
0/464
|
0.00%
0/468
|
0.21%
1/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/464
|
0.00%
0/468
|
0.21%
1/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Nervous system disorders
Syncope
|
0.43%
2/464
|
0.00%
0/468
|
0.00%
0/472
|
0.38%
2/528
|
0.00%
0/515
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Psychiatric disorders
Delirium
|
0.00%
0/464
|
0.00%
0/468
|
0.21%
1/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Renal and urinary disorders
Bladder cancer
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Renal and urinary disorders
Renal failure
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.38%
2/528
|
0.00%
0/515
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.65%
3/464
|
0.43%
2/468
|
0.00%
0/472
|
0.38%
2/528
|
0.58%
3/515
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/464
|
0.21%
1/468
|
0.21%
1/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.65%
3/464
|
0.00%
0/468
|
0.00%
0/472
|
0.76%
4/528
|
0.00%
0/515
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.22%
1/464
|
0.21%
1/468
|
0.00%
0/472
|
0.00%
0/528
|
1.2%
6/515
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.43%
2/464
|
0.64%
3/468
|
0.21%
1/472
|
0.76%
4/528
|
0.19%
1/515
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Surgical and medical procedures
Mastectomy
|
0.00%
0/464
|
0.21%
1/468
|
0.00%
0/472
|
0.00%
0/528
|
0.19%
1/515
|
|
Surgical and medical procedures
Tumour excision
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Vascular disorders
Cerebrovascular accident
|
0.00%
0/464
|
0.00%
0/468
|
0.21%
1/472
|
0.19%
1/528
|
0.00%
0/515
|
|
Vascular disorders
Deep vein thrombosis
|
0.43%
2/464
|
0.21%
1/468
|
0.00%
0/472
|
0.76%
4/528
|
0.58%
3/515
|
|
Vascular disorders
Epistaxis
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.19%
1/515
|
|
Vascular disorders
Haematoma
|
0.00%
0/464
|
0.00%
0/468
|
0.21%
1/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Vascular disorders
Hypotension
|
0.22%
1/464
|
0.21%
1/468
|
0.00%
0/472
|
0.57%
3/528
|
0.00%
0/515
|
|
Vascular disorders
Orthostatic hypotension
|
0.22%
1/464
|
0.00%
0/468
|
0.00%
0/472
|
0.00%
0/528
|
0.00%
0/515
|
|
Vascular disorders
Septic phlebitis
|
0.00%
0/464
|
0.00%
0/468
|
0.00%
0/472
|
0.19%
1/528
|
0.00%
0/515
|
Other adverse events
| Measure |
Cycle 1 APF530 5 mg
n=464 participants at risk
Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
|
Cycle 1 APF530 10 mg
n=468 participants at risk
Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
|
Cycle 1 Aloxi 0.25 mg
n=472 participants at risk
Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
|
Cycles 2-4 APF530 5 mg
n=528 participants at risk
Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population
|
Cycle 2-4 APF530 10 mg
n=515 participants at risk
Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.9%
46/464
|
9.0%
42/468
|
7.2%
34/472
|
16.3%
86/528
|
16.9%
87/515
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.4%
39/464
|
10.3%
48/468
|
8.1%
38/472
|
8.7%
46/528
|
8.2%
42/515
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.9%
18/464
|
3.4%
16/468
|
2.8%
13/472
|
6.1%
32/528
|
7.0%
36/515
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
21/464
|
2.8%
13/468
|
5.9%
28/472
|
2.8%
15/528
|
4.7%
24/515
|
|
Gastrointestinal disorders
Constipation
|
13.1%
61/464
|
15.4%
72/468
|
13.1%
62/472
|
14.8%
78/528
|
15.3%
79/515
|
|
Gastrointestinal disorders
Diarrhoea
|
10.1%
47/464
|
9.4%
44/468
|
8.3%
39/472
|
9.7%
51/528
|
13.4%
69/515
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
16/464
|
3.4%
16/468
|
3.4%
16/472
|
6.1%
32/528
|
5.8%
30/515
|
|
Gastrointestinal disorders
Nausea
|
11.9%
55/464
|
12.4%
58/468
|
8.7%
41/472
|
12.5%
66/528
|
14.2%
73/515
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
24/464
|
3.8%
18/468
|
2.8%
13/472
|
5.3%
28/528
|
4.9%
25/515
|
|
General disorders
Asthenia
|
5.0%
23/464
|
4.5%
21/468
|
6.4%
30/472
|
11.4%
60/528
|
7.6%
39/515
|
|
General disorders
Fatigue
|
13.4%
62/464
|
13.2%
62/468
|
11.0%
52/472
|
15.2%
80/528
|
18.3%
94/515
|
|
General disorders
Injection site bruising
|
16.8%
78/464
|
19.9%
93/468
|
8.7%
41/472
|
23.5%
124/528
|
29.7%
153/515
|
|
General disorders
Injection site erythema
|
7.1%
33/464
|
10.9%
51/468
|
3.0%
14/472
|
11.0%
58/528
|
11.8%
61/515
|
|
General disorders
Injection site haemorrhage
|
4.3%
20/464
|
3.8%
18/468
|
2.1%
10/472
|
6.6%
35/528
|
6.0%
31/515
|
|
General disorders
Injection site nodule
|
4.7%
22/464
|
10.7%
50/468
|
0.64%
3/472
|
10.8%
57/528
|
17.5%
90/515
|
|
General disorders
Injection site pain
|
3.4%
16/464
|
7.1%
33/468
|
1.1%
5/472
|
6.4%
34/528
|
7.2%
37/515
|
|
General disorders
Oedema peripheral
|
2.8%
13/464
|
1.5%
7/468
|
1.7%
8/472
|
5.3%
28/528
|
6.0%
31/515
|
|
General disorders
Pyrexia
|
3.2%
15/464
|
3.2%
15/468
|
4.0%
19/472
|
6.1%
32/528
|
4.7%
24/515
|
|
Infections and infestations
Upper respiratory tract infection
|
0.86%
4/464
|
0.85%
4/468
|
1.9%
9/472
|
5.5%
29/528
|
4.1%
21/515
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.8%
13/464
|
3.6%
17/468
|
3.6%
17/472
|
4.5%
24/528
|
6.2%
32/515
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
14/464
|
2.4%
11/468
|
2.1%
10/472
|
6.6%
35/528
|
5.6%
29/515
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
10/464
|
2.1%
10/468
|
2.1%
10/472
|
5.5%
29/528
|
4.1%
21/515
|
|
Nervous system disorders
Dizziness
|
3.0%
14/464
|
3.6%
17/468
|
1.7%
8/472
|
4.0%
21/528
|
5.6%
29/515
|
|
Nervous system disorders
Headache
|
6.7%
31/464
|
10.0%
47/468
|
9.3%
44/472
|
7.2%
38/528
|
8.5%
44/515
|
|
Nervous system disorders
Insomnia
|
4.3%
20/464
|
5.3%
25/468
|
2.3%
11/472
|
5.1%
27/528
|
4.5%
23/515
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
11/464
|
2.4%
11/468
|
3.0%
14/472
|
5.9%
31/528
|
6.6%
34/515
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
13/464
|
2.6%
12/468
|
1.9%
9/472
|
6.6%
35/528
|
3.7%
19/515
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.1%
19/464
|
6.6%
31/468
|
5.3%
25/472
|
15.5%
82/528
|
13.4%
69/515
|
Additional Information
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