Trial Outcomes & Findings for PI-88 in Hepatocellular Carcinoma After Hepatectomy (NCT NCT00247728)
NCT ID: NCT00247728
Last Updated: 2022-06-23
Results Overview
The tumor non-recurrence rate at the end of the 48-week study period
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
172 participants
Primary outcome timeframe
Week 48
Results posted on
2022-06-23
Participant Flow
215 patients were screened between June 2004 and December 2006. Patients were randomized in balanced blocks per center.
Participant milestones
| Measure |
Group A - Untreated Control
untreated control with standard of care
|
Group B - 160 mg PI-88/Day
160 mg PI-88 via subcutaneous injection for four consecutive days per week, every week
|
Group C - 250 mg PI-88/Day
250 mg PI-88 via subcutaneous injection for four consecutive days per week, every week
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
57
|
57
|
|
Overall Study
COMPLETED
|
55
|
51
|
43
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PI-88 in Hepatocellular Carcinoma After Hepatectomy
Baseline characteristics by cohort
| Measure |
Group A - Untreated Control
n=58 Participants
untreated control with standard of care, ITT population
|
Group B - 160 mg PI-88/Day
n=56 Participants
160 mg PI-88 via subcutaneous injection for four consecutive days per week, every week, ITT population
|
Group C - 250 mg PI-88/Day
n=54 Participants
250 mg PI-88 via subcutaneous injection for four consecutive days per week, every week, ITT population
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.96 years
STANDARD_DEVIATION 12.54 • n=5 Participants
|
51.47 years
STANDARD_DEVIATION 12.57 • n=7 Participants
|
52.41 years
STANDARD_DEVIATION 12.03 • n=5 Participants
|
52.39 years
STANDARD_DEVIATION 12.38 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
58 participants
n=5 Participants
|
56 participants
n=7 Participants
|
54 participants
n=5 Participants
|
168 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: ITT population, defined as all randomized subjects who had received at least one dose of study medication (if in a treatment arm) and who had undergone at least one study visit following randomization, including an abdominal CT scan.
The tumor non-recurrence rate at the end of the 48-week study period
Outcome measures
| Measure |
Group A - Untreated Control
n=58 Participants
untreated control with standard of care
|
Group B - 160 mg PI-88/Day
n=56 Participants
160 mg PI-88 via subcutaneous injection for four consecutive days per week, every week
|
Group C - 250 mg PI-88/Day
n=54 Participants
250 mg PI-88 via subcutaneous injection for four consecutive days per week, every week
|
|---|---|---|---|
|
Tumour Non-recurrence Rate
|
32 Participants
|
40 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: until confirmed tumour recurrence, or for a maximum of 48 weeksPopulation: ITT population, defined as all randomized subjects who had received at least one dose of study medication (if in a treatment arm) and who had undergone at least one study visit following randomization, including an abdominal CT scan.
Time to recurrence during the 48-week study period
Outcome measures
| Measure |
Group A - Untreated Control
n=58 Participants
untreated control with standard of care
|
Group B - 160 mg PI-88/Day
n=56 Participants
160 mg PI-88 via subcutaneous injection for four consecutive days per week, every week
|
Group C - 250 mg PI-88/Day
n=54 Participants
250 mg PI-88 via subcutaneous injection for four consecutive days per week, every week
|
|---|---|---|---|
|
Time to Recurrence
|
NA Weeks
The median TTR was unable to be compared among the three study groups because, in all groups, less than 50% of subjects had documented evidence of tumor recurrence by the end of the study.
of tumor recurrence.
|
NA Weeks
The median TTR was unable to be compared among the three study groups because, in all groups, less than 50% of subjects had documented evidence of tumor recurrence by the end of the study.
|
NA Weeks
The median TTR was unable to be compared among the three study groups because, in all groups, less than 50% of subjects had documented evidence of tumor recurrence by the end of the study.
|
SECONDARY outcome
Timeframe: Week 48Population: ITT population, defined as all randomized subjects who had received at least one dose of study medication (if in a treatment arm) and who had undergone at least one study visit following randomization, including an abdominal CT scan.
Survival rate at the end of the 48-week study period
Outcome measures
| Measure |
Group A - Untreated Control
n=58 Participants
untreated control with standard of care
|
Group B - 160 mg PI-88/Day
n=56 Participants
160 mg PI-88 via subcutaneous injection for four consecutive days per week, every week
|
Group C - 250 mg PI-88/Day
n=54 Participants
250 mg PI-88 via subcutaneous injection for four consecutive days per week, every week
|
|---|---|---|---|
|
Survival Rate
|
54 Participants
|
51 Participants
|
51 Participants
|
Adverse Events
Group A - Untreated Control
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Group B - 160 mg PI-88/Day
Serious events: 7 serious events
Other events: 55 other events
Deaths: 0 deaths
Group C - 250 mg PI-88/Day
Serious events: 8 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A - Untreated Control
n=58 participants at risk
untreated control with standard of care in safety population defined as all randomized subjects, who had at least one assessment following randomization.
|
Group B - 160 mg PI-88/Day
n=57 participants at risk
160 mg PI-88 via subcutaneous injection for four consecutive days per week, every week, safety population (defined as all randomized subjects, who had at least one assessment following randomization)
|
Group C - 250 mg PI-88/Day
n=57 participants at risk
250 mg PI-88 via subcutaneous injection for four consecutive days per week, every week, safety population defined as all randomized subjects, who had at least one assessment following randomization
|
|---|---|---|---|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
Infections and infestations
Carbuncle
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 2 • During the course of the study (maximum 48 weeks)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
|
General disorders
Edema peripheral
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
|
Gastrointestinal disorders
Gastric ulcer hemorrhage
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
1.7%
1/58 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
|
General disorders
Gingival bleeding
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
Nervous system disorders
Hemorrhage intracranial
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
|
Vascular disorders
Hypovalemic shock
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
General disorders
Ileus
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.7%
1/58 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
Other adverse events
| Measure |
Group A - Untreated Control
n=58 participants at risk
untreated control with standard of care in safety population defined as all randomized subjects, who had at least one assessment following randomization.
|
Group B - 160 mg PI-88/Day
n=57 participants at risk
160 mg PI-88 via subcutaneous injection for four consecutive days per week, every week, safety population (defined as all randomized subjects, who had at least one assessment following randomization)
|
Group C - 250 mg PI-88/Day
n=57 participants at risk
250 mg PI-88 via subcutaneous injection for four consecutive days per week, every week, safety population defined as all randomized subjects, who had at least one assessment following randomization
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperalbuminaemia
|
1.7%
1/58 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 5 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
12.3%
7/57 • Number of events 8 • During the course of the study (maximum 48 weeks)
|
15.8%
9/57 • Number of events 9 • During the course of the study (maximum 48 weeks)
|
|
General disorders
Injection site pain
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
10.5%
6/57 • Number of events 6 • During the course of the study (maximum 48 weeks)
|
7.0%
4/57 • Number of events 4 • During the course of the study (maximum 48 weeks)
|
|
Investigations
ALT increased
|
6.9%
4/58 • Number of events 6 • During the course of the study (maximum 48 weeks)
|
24.6%
14/57 • Number of events 21 • During the course of the study (maximum 48 weeks)
|
33.3%
19/57 • Number of events 33 • During the course of the study (maximum 48 weeks)
|
|
Investigations
APPT prolonged
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
35.1%
20/57 • Number of events 20 • During the course of the study (maximum 48 weeks)
|
31.6%
18/57 • Number of events 22 • During the course of the study (maximum 48 weeks)
|
|
Investigations
AST increased
|
5.2%
3/58 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
17.5%
10/57 • Number of events 18 • During the course of the study (maximum 48 weeks)
|
22.8%
13/57 • Number of events 24 • During the course of the study (maximum 48 weeks)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.7%
1/58 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
14.0%
8/57 • Number of events 8 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
Gastrointestinal disorders
Abdominal distension
|
8.6%
5/58 • Number of events 5 • During the course of the study (maximum 48 weeks)
|
10.5%
6/57 • Number of events 6 • During the course of the study (maximum 48 weeks)
|
8.8%
5/57 • Number of events 5 • During the course of the study (maximum 48 weeks)
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
4/58 • Number of events 5 • During the course of the study (maximum 48 weeks)
|
10.5%
6/57 • Number of events 6 • During the course of the study (maximum 48 weeks)
|
8.8%
5/57 • Number of events 6 • During the course of the study (maximum 48 weeks)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
1/58 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
8.8%
5/57 • Number of events 7 • During the course of the study (maximum 48 weeks)
|
14.0%
8/57 • Number of events 8 • During the course of the study (maximum 48 weeks)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
10.5%
6/57 • Number of events 7 • During the course of the study (maximum 48 weeks)
|
22.8%
13/57 • Number of events 13 • During the course of the study (maximum 48 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
3/58 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 2 • During the course of the study (maximum 48 weeks)
|
|
Gastrointestinal disorders
Ascites
|
1.7%
1/58 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
10.5%
6/57 • Number of events 9 • During the course of the study (maximum 48 weeks)
|
7.0%
4/57 • Number of events 8 • During the course of the study (maximum 48 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
2/58 • Number of events 2 • During the course of the study (maximum 48 weeks)
|
3.5%
2/57 • Number of events 2 • During the course of the study (maximum 48 weeks)
|
8.8%
5/57 • Number of events 6 • During the course of the study (maximum 48 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.1%
7/58 • Number of events 7 • During the course of the study (maximum 48 weeks)
|
8.8%
5/57 • Number of events 8 • During the course of the study (maximum 48 weeks)
|
8.8%
5/57 • Number of events 6 • During the course of the study (maximum 48 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/58 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
12.3%
7/57 • Number of events 9 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
|
Nervous system disorders
Dizziness
|
8.6%
5/58 • Number of events 6 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 2 • During the course of the study (maximum 48 weeks)
|
10.5%
6/57 • Number of events 6 • During the course of the study (maximum 48 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
2/58 • Number of events 2 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
General disorders
Fatigue
|
1.7%
1/58 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 6 • During the course of the study (maximum 48 weeks)
|
|
Nervous system disorders
Headache
|
3.4%
2/58 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
7.0%
4/57 • Number of events 4 • During the course of the study (maximum 48 weeks)
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 4 • During the course of the study (maximum 48 weeks)
|
|
General disorders
Injection site reaction
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
7.0%
4/57 • Number of events 6 • During the course of the study (maximum 48 weeks)
|
7.0%
4/57 • Number of events 4 • During the course of the study (maximum 48 weeks)
|
|
Psychiatric disorders
Insomnia
|
17.2%
10/58 • Number of events 10 • During the course of the study (maximum 48 weeks)
|
19.3%
11/57 • Number of events 13 • During the course of the study (maximum 48 weeks)
|
19.3%
11/57 • Number of events 16 • During the course of the study (maximum 48 weeks)
|
|
General disorders
Malaise
|
5.2%
3/58 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
7.0%
4/57 • Number of events 5 • During the course of the study (maximum 48 weeks)
|
8.8%
5/57 • Number of events 6 • During the course of the study (maximum 48 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
3.5%
2/57 • Number of events 2 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 4 • During the course of the study (maximum 48 weeks)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
7.0%
4/57 • Number of events 4 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
1/58 • Number of events 2 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/58 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
8.8%
5/57 • Number of events 5 • During the course of the study (maximum 48 weeks)
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.4%
2/58 • Number of events 2 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
10.5%
6/57 • Number of events 20 • During the course of the study (maximum 48 weeks)
|
7.0%
4/57 • Number of events 24 • During the course of the study (maximum 48 weeks)
|
|
General disorders
Oedema peripheral
|
1.7%
1/58 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
7.0%
4/57 • Number of events 4 • During the course of the study (maximum 48 weeks)
|
7.0%
4/57 • Number of events 7 • During the course of the study (maximum 48 weeks)
|
|
Investigations
PT prolongation
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
|
Gastrointestinal disorders
Periodontits
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
0.00%
0/57 • During the course of the study (maximum 48 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 4 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/58 • During the course of the study (maximum 48 weeks)
|
8.8%
5/57 • Number of events 5 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
|
Skin and subcutaneous tissue disorders
Puritus
|
1.7%
1/58 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
3.5%
2/57 • Number of events 2 • During the course of the study (maximum 48 weeks)
|
12.3%
7/57 • Number of events 7 • During the course of the study (maximum 48 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
1/58 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
|
Psychiatric disorders
Sleep disorders
|
1.7%
1/58 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
1.8%
1/57 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
|
Blood and lymphatic system disorders
Splenomegaly
|
5.2%
3/58 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
12.3%
7/57 • Number of events 7 • During the course of the study (maximum 48 weeks)
|
5.3%
3/57 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
1/58 • Number of events 1 • During the course of the study (maximum 48 weeks)
|
10.5%
6/57 • Number of events 14 • During the course of the study (maximum 48 weeks)
|
12.3%
7/57 • Number of events 18 • During the course of the study (maximum 48 weeks)
|
|
Infections and infestations
Upper respiratory tract infection
|
24.1%
14/58 • Number of events 15 • During the course of the study (maximum 48 weeks)
|
14.0%
8/57 • Number of events 8 • During the course of the study (maximum 48 weeks)
|
17.5%
10/57 • Number of events 12 • During the course of the study (maximum 48 weeks)
|
|
Injury, poisoning and procedural complications
Wound complication
|
3.4%
2/58 • Number of events 3 • During the course of the study (maximum 48 weeks)
|
8.8%
5/57 • Number of events 5 • During the course of the study (maximum 48 weeks)
|
3.5%
2/57 • Number of events 2 • During the course of the study (maximum 48 weeks)
|
Additional Information
Director of Regulatory Affairs and Clinical Development
Progen Pharmaceuticals Ltd
Phone: +61 (0)7 38423333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place