Trial Outcomes & Findings for PROspective Non-interventional Open laBEl Trial for TARGIN in Korean Patients With Cancer Pain (NCT NCT01719757)
NCT ID: NCT01719757
Last Updated: 2016-08-19
Results Overview
Primary objective: Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline (visit 1) to study end (visit 2). NRS score was measured from 0 (No pain) to 10(worst pain imaginable).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
359 participants
Primary outcome timeframe
4 weeks
Results posted on
2016-08-19
Participant Flow
Safety set: 359 ITT set: 304
Participant milestones
| Measure |
Oxycodone/Naloxone
Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Oxycodone/Naloxone: Twice daily
|
|---|---|
|
Overall Study
STARTED
|
359
|
|
Overall Study
COMPLETED
|
258
|
|
Overall Study
NOT COMPLETED
|
101
|
Reasons for withdrawal
| Measure |
Oxycodone/Naloxone
Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Oxycodone/Naloxone: Twice daily
|
|---|---|
|
Overall Study
Adverse Event
|
38
|
|
Overall Study
Withdrawal by Subject
|
15
|
|
Overall Study
Lost to Follow-up
|
20
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
well controlled pain
|
27
|
Baseline Characteristics
PROspective Non-interventional Open laBEl Trial for TARGIN in Korean Patients With Cancer Pain
Baseline characteristics by cohort
| Measure |
Oxycodone/Naloxone
n=359 Participants
Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Oxycodone/Naloxone: Twice daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
179 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
180 Participants
n=93 Participants
|
|
Age, Continuous
|
67.73 years
STANDARD_DEVIATION 11.07 • n=93 Participants
|
|
Sex: Female, Male
Female
|
134 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
225 Participants
n=93 Participants
|
|
Region of Enrollment
Korea, Republic of
|
359 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Intent to treat analysis set: 304
Primary objective: Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline (visit 1) to study end (visit 2). NRS score was measured from 0 (No pain) to 10(worst pain imaginable).
Outcome measures
| Measure |
Oxycodone/Naloxone
n=304 Participants
Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Oxycodone/Naloxone: Twice daily
|
Subject
For overall satisfaction assessement of oxycodone/naloxone by subject
|
|---|---|---|
|
Change in Numeric Rating Scales (NRS) Score
|
-1.89 units on a scale
Standard Deviation 2.16
|
—
|
SECONDARY outcome
Timeframe: 4weeksPopulation: Intent to treat analysis set: 304
If ECOG P.S score is increased from baseline to visit2, the results mean that QOL was worse. ECOG P.S grade: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work,2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours,4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair,5=Death.
Outcome measures
| Measure |
Oxycodone/Naloxone
n=304 Participants
Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Oxycodone/Naloxone: Twice daily
|
Subject
For overall satisfaction assessement of oxycodone/naloxone by subject
|
|---|---|---|
|
Change of Eastern Cooperative Oncology Group(ECOG) Performance Status
|
0.08 Score
Standard Deviation 0.52
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Intent to treat analysis set(Last observational carried forward)
Constipation assessment(5-point scale; 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe, for the patient's judgment of the intensity of symptoms)
Outcome measures
| Measure |
Oxycodone/Naloxone
n=304 Participants
Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Oxycodone/Naloxone: Twice daily
|
Subject
For overall satisfaction assessement of oxycodone/naloxone by subject
|
|---|---|---|
|
Change of Constipation Assessment From Baseline to Visit 2(End Visit)
|
-0.03 score
Standard Deviation 0.67
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Intent to treat analysis set(Last observational carried forward)
The overall satisfactions by investigators \& subjects were assessed 5 steps such as Very good, Good, Satisfactory, Bad, Very bad.
Outcome measures
| Measure |
Oxycodone/Naloxone
n=304 Participants
Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Oxycodone/Naloxone: Twice daily
|
Subject
n=304 Participants
For overall satisfaction assessement of oxycodone/naloxone by subject
|
|---|---|---|
|
Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject
Very good
|
24 participants
|
12 participants
|
|
Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject
Good
|
80 participants
|
78 participants
|
|
Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject
Satisfactory
|
146 participants
|
156 participants
|
|
Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject
Bad
|
53 participants
|
55 participants
|
|
Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject
Very Bad
|
1 participants
|
3 participants
|
Adverse Events
Oxycodone/Naloxone
Serious events: 51 serious events
Other events: 227 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oxycodone/Naloxone
n=359 participants at risk
Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Oxycodone/Naloxone: Twice daily
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
0.84%
3/359 • Number of events 3 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
5/359 • Number of events 5 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Haematochezia
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Ascites
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Ileus
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Melaena
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Pyrexia
|
0.84%
3/359 • Number of events 3 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Asthenia
|
1.7%
6/359 • Number of events 6 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Fatigue
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Disease progression
|
1.1%
4/359 • Number of events 4 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Chest discomfort
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Pain
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Infections and infestations
Pneumonia
|
0.84%
3/359 • Number of events 3 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Infections and infestations
Sepsis
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Infections and infestations
Wound infection
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Vascular disorders
Embolism
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Investigations
Weight decreased
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Psychiatric disorders
Delirium
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
Other adverse events
| Measure |
Oxycodone/Naloxone
n=359 participants at risk
Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Oxycodone/Naloxone: Twice daily
|
|---|---|
|
Infections and infestations
Sepsis
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Infections and infestations
Tuberculosis
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Infections and infestations
Oral candidiasis
|
0.84%
3/359 • Number of events 3 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Infections and infestations
Pneumonia
|
0.84%
3/359 • Number of events 3 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Infections and infestations
Wound infection
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
8/359 • Number of events 9 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
5/359 • Number of events 5 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
5/359 • Number of events 5 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
7/359 • Number of events 7 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
4/359 • Number of events 6 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Infections and infestations
Furuncle
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Infections and infestations
Herpes zoster
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Infections and infestations
Localised infection
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Constipation
|
16.4%
59/359 • Number of events 61 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Nausea
|
13.4%
48/359 • Number of events 52 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
25/359 • Number of events 28 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
22/359 • Number of events 29 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.9%
14/359 • Number of events 15 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
9/359 • Number of events 10 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Stomatitis
|
2.5%
9/359 • Number of events 9 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.4%
5/359 • Number of events 5 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
5/359 • Number of events 5 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
4/359 • Number of events 4 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
4/359 • Number of events 4 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Haematochezia
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Ascites
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Ileus
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Melaena
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Oral pain
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Pyrexia
|
6.7%
24/359 • Number of events 33 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Asthenia
|
5.6%
20/359 • Number of events 23 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Fatigue
|
1.9%
7/359 • Number of events 7 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Chills
|
1.7%
6/359 • Number of events 7 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Disease progression
|
1.7%
6/359 • Number of events 6 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Chest discomfort
|
1.1%
4/359 • Number of events 4 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Oedema
|
1.1%
4/359 • Number of events 5 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Pain
|
1.1%
4/359 • Number of events 4 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Oedema peripheral
|
0.84%
3/359 • Number of events 3 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Catheter site oedema
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Face oedema
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Generalised oedema
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
General disorders
Non-cardiac chest pain
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
36/359 • Number of events 41 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.56%
2/359 • Number of events 3 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.56%
2/359 • Number of events 3 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Nervous system disorders
Dizziness
|
4.2%
15/359 • Number of events 15 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Nervous system disorders
Headache
|
2.2%
8/359 • Number of events 8 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Nervous system disorders
Hypersomnia
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Nervous system disorders
Somnolence
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Nervous system disorders
Speech disorder
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Nervous system disorders
Amnesia
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Nervous system disorders
Cognitive disorder
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Nervous system disorders
Hypoaesthesia
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Nervous system disorders
Muscle spasticity
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Nervous system disorders
Neuralgia
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.28%
1/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
8/359 • Number of events 8 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
7/359 • Number of events 7 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.7%
6/359 • Number of events 6 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.7%
6/359 • Number of events 6 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.84%
3/359 • Number of events 3 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
4/359 • Number of events 4 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
4/359 • Number of events 4 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Renal and urinary disorders
Dysuria
|
1.7%
6/359 • Number of events 6 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Renal and urinary disorders
Bladder dilatation
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Renal and urinary disorders
Haematuria
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Renal and urinary disorders
Pollakiuria
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Vascular disorders
Flushing
|
1.1%
4/359 • Number of events 4 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Vascular disorders
Hypertension
|
1.1%
4/359 • Number of events 4 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Vascular disorders
Embolism
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Vascular disorders
Hypotension
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Investigations
Alanine aminotransferase increased
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
0.56%
2/359 • Number of events 2 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Investigations
Neutrophil count decreased
|
0.56%
2/359 • Number of events 3 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Investigations
Blood iron decreased
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Investigations
Platelet count decreased
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Investigations
Weight decreased
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Investigations
Weight increased
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Psychiatric disorders
Insomnia
|
1.4%
5/359 • Number of events 7 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Psychiatric disorders
Anxiety
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Psychiatric disorders
Confusional state
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Psychiatric disorders
Delirium
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Immune system disorders
Hypersensitivity
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.28%
1/359 • Number of events 1 • Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place