Trial Outcomes & Findings for An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting (NCT NCT01363479)
NCT ID: NCT01363479
Last Updated: 2021-09-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
743 participants
Primary outcome timeframe
0-24 hours
Results posted on
2021-09-22
Participant Flow
A total of 743 patients were randomized (ITT population), 739 received study medications (oral or I.V. palonosetron plus dexamethasone, safety population), 738 received study medications (oral or I.V. palonosetron plus dexamethasone, safety population) and chemotherapy (FAS population)
Participant milestones
| Measure |
Oral Palonosteron Plus Dexamethasone
Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Oral palonosetron
Dexamethasone
|
I.V. Palonosetron Plus Dexamethasone
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
I.V. palonosetron
Dexamethasone
|
|---|---|---|
|
Overall Study
STARTED
|
371
|
372
|
|
Overall Study
COMPLETED
|
359
|
351
|
|
Overall Study
NOT COMPLETED
|
12
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting
Baseline characteristics by cohort
| Measure |
Oral Palonosteron Plus Dexamethasone
n=370 Participants
Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Oral palonosetron
Dexamethasone
|
I.V. Palonosetron Plus Dexamethasone
n=369 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
I.V. palonosetron
Dexamethasone
|
Total
n=739 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 9.41 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 9.92 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 9.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
219 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
436 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
321 participants
n=5 Participants
|
320 participants
n=7 Participants
|
641 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
49 participants
n=5 Participants
|
47 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-24 hoursPopulation: Full Analysis Set i.e. patients receiving study drugs and chemotherapy
Outcome measures
| Measure |
Oral Palonosteron Plus Dexamethasone
n=369 Participants
Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Oral palonosetron
Dexamethasone
|
I.V. Palonosetron Plus Dexamethasone
n=369 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
I.V. palonosetron
Dexamethasone
|
|---|---|---|
|
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication
|
89.4 percentage of responders
Interval 85.9 to 92.2
|
86.2 percentage of responders
Interval 82.3 to 89.3
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: FAS i.e. patients receiving study drugs and chemotherapy
Outcome measures
| Measure |
Oral Palonosteron Plus Dexamethasone
n=369 Participants
Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Oral palonosetron
Dexamethasone
|
I.V. Palonosetron Plus Dexamethasone
n=369 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
I.V. palonosetron
Dexamethasone
|
|---|---|---|
|
Percentage of Patients With no Emesis
|
90.2 percentage of responders
Interval 86.8 to 92.9
|
86.7 percentage of responders
Interval 82.9 to 89.8
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: FAS i.e. patients receiving study drugs and chemotherapy
Outcome measures
| Measure |
Oral Palonosteron Plus Dexamethasone
n=369 Participants
Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Oral palonosetron
Dexamethasone
|
I.V. Palonosetron Plus Dexamethasone
n=369 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
I.V. palonosetron
Dexamethasone
|
|---|---|---|
|
Percentage of Patients With no Rescue Medication
|
94.6 percentage of responders
Interval 91.8 to 96.5
|
93.2 percentage of responders
Interval 90.2 to 95.4
|
Adverse Events
Oral Palonosteron Plus Dexamethasone
Serious events: 36 serious events
Other events: 168 other events
Deaths: 0 deaths
I.V. Palonosetron Plus Dexamethasone
Serious events: 36 serious events
Other events: 171 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Palonosteron Plus Dexamethasone
n=370 participants at risk
Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Oral palonosetron
Dexamethasone
|
I.V. Palonosetron Plus Dexamethasone
n=369 participants at risk
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
I.V. palonosetron
Dexamethasone
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
1.6%
6/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.81%
3/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
1.1%
4/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Blood and lymphatic system disorders
Leucopenia
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
5/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
2.4%
9/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.54%
2/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
1.4%
5/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.54%
2/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Cardiac disorders
Myocardial infarction
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Cardiac disorders
Myocardial ischaemia
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Gastrointestinal disorders
Abdominal pain
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Gastrointestinal disorders
Aphagia
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Gastrointestinal disorders
Constipation
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Gastrointestinal disorders
Diarrhoea
|
0.81%
3/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Gastrointestinal disorders
Nausea
|
0.81%
3/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Gastrointestinal disorders
Proctitis ulcerative
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Gastrointestinal disorders
Vomiting
|
0.81%
3/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.54%
2/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
General disorders
Asthenia
|
0.81%
3/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
General disorders
Chest Pain
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
General disorders
Death
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
1.1%
4/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
General disorders
Fatigue
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
General disorders
General physical health deterioration
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
General disorders
Malaise
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
General disorders
Multi-organ failure
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Infections and infestations
Pneumonia
|
0.81%
3/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Injury, poisoning and procedural complications
Concussion
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Investigations
Blood creatinine increased
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Investigations
C-reactive protein increased
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Metabolism and nutrition disorders
Dehydration
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.54%
2/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Nervous system disorders
Cerebrovascular accident
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Nervous system disorders
Ischaemic stroke
|
0.54%
2/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Nervous system disorders
Loss of consciousness
|
0.54%
2/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Nervous system disorders
Syncope
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.54%
2/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Renal and urinary disorders
Renal failure acute
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.54%
2/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.54%
2/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.54%
2/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Respiratory, thoracic and mediastinal disorders
Laryngotracheal oedema
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Vascular disorders
Circulatory collapse
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Vascular disorders
Deep vein thrombosis
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Vascular disorders
Femoral artery embolism
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Vascular disorders
Hypertension
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Vascular disorders
Hypotension
|
0.00%
0/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.27%
1/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Vascular disorders
Shock haemorrhagic
|
0.27%
1/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
0.00%
0/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
Other adverse events
| Measure |
Oral Palonosteron Plus Dexamethasone
n=370 participants at risk
Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Oral palonosetron
Dexamethasone
|
I.V. Palonosetron Plus Dexamethasone
n=369 participants at risk
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
I.V. palonosetron
Dexamethasone
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
5.7%
21/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
7.6%
28/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Gastrointestinal disorders
Constipation
|
6.2%
23/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
5.4%
20/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
General disorders
Asthenia
|
8.4%
31/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
7.6%
28/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.7%
21/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
3.0%
11/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Nervous system disorders
Headache
|
2.4%
9/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
5.7%
21/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Investigations
Investigations
|
11.1%
41/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
12.2%
45/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorder
|
5.9%
22/370 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
4.9%
18/369 • Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as "ongoing."
|
Additional Information
Marco Palmas MD, Head of Clinical Development
Helsinn Healthcare SA
Phone: +41919852121
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor and investigator(s) agree that no publications discussing trials' results will occur until release of final report. Sponsor has no objections if the investigators publish study results, however the investigator is requested to contact the sponsor before publishing, to prevent premature disclosure of data and is not intended as a restrictive measure concerning results or opinions of investigators.
- Publication restrictions are in place
Restriction type: OTHER