Trial Outcomes & Findings for Study of the Trifunctional Antibody Catumaxomab to Treat Recurrent Symptomatic Malignant Ascites (NCT NCT00326885)
NCT ID: NCT00326885
Last Updated: 2018-10-17
Results Overview
The parameter to be estimated is the proportion of patients who achieve at least a 4-fold increase in their puncture/paracentesis-free interval. The pretreatment interval is defined as the length of time between the patient's most recent paracentesis (baseline) and the subsequent paracentesis necessitated by her increasing ascites-related symptoms. The post-treatment interval is defined as the time between the last dose of catumaxomab plus 1 day to the time of recurrence of ascites requiring therapeutic paracentesis or death, whichever occurred sooner.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
6 months
Results posted on
2018-10-17
Participant Flow
40 patients were recruited and 32 patients were treated and evaluable. For analyses, there were 32 patients in the Full Analysis Set (FAS), 14 patients in the Per-Protocol (PP) population, and 32 patients in the Safety population.
Eligible patients must have undergone at least 1 therapeutic paracentesis (the most recent paracentesis) within 4 weeks prior to the baseline paracentesis.
Participant milestones
| Measure |
Catumaxomab
Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Catumaxomab
Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Hospice withdrew consent
|
2
|
Baseline Characteristics
Study of the Trifunctional Antibody Catumaxomab to Treat Recurrent Symptomatic Malignant Ascites
Baseline characteristics by cohort
| Measure |
Catumaxomab
n=32 Participants
Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 10.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe parameter to be estimated is the proportion of patients who achieve at least a 4-fold increase in their puncture/paracentesis-free interval. The pretreatment interval is defined as the length of time between the patient's most recent paracentesis (baseline) and the subsequent paracentesis necessitated by her increasing ascites-related symptoms. The post-treatment interval is defined as the time between the last dose of catumaxomab plus 1 day to the time of recurrence of ascites requiring therapeutic paracentesis or death, whichever occurred sooner.
Outcome measures
| Measure |
Catumaxomab
n=31 Participants
Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
|
|---|---|
|
The Proportion of Patients Who Achieved at Least a 4-fold Increase of Puncture/Paracentesis-free Interval Following Catumaxomab Relative to Their Pre-treatment Interval.
|
0.226 proportion of patients
|
PRIMARY outcome
Timeframe: 180 daysThe parameter to be tested is the ratio of the post-treatment puncture/paracentesis-free interval divided by the pre-treatment puncture/paracentesis-free interval. The pre-treatment interval is defined as the length of time between the patient's most recent paracentesis (baseline) and the subsequent paracentesis necessitated by her increasing ascites-related symptoms. The post-treatment interval is defined as the time between the last dose of catumaxomab plus 1 day to the time of recurrence of ascites requiring therapeutic paracentesis or death, whichever occurred sooner.
Outcome measures
| Measure |
Catumaxomab
n=31 Participants
Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
|
|---|---|
|
Increase of Paracentesis/Puncture-free Interval (Ratio)
|
2 fold
Interval 0.15 to 60.0
|
SECONDARY outcome
Timeframe: ≥6 monthsPopulation: Full analysis set (FAS) Per protocol (PP)
Puncture/Paracentesis-free Survival (PuFS), Defined as the Number of Days Between the Date of Last Dose and the Date of Documented End of Study (EoS) Paracentesis or Death, Whichever Occurred First
Outcome measures
| Measure |
Catumaxomab
n=32 Participants
Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
|
|---|---|
|
Puncture/Paracentesis-free Survival (PuFS)
|
4.2 weeks
Interval 2.1 to 7.6
|
SECONDARY outcome
Timeframe: ≥ 6 monthsOverall survival is defined as the interval from the date of first dose to the date of death.
Outcome measures
| Measure |
Catumaxomab
n=32 Participants
Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
|
|---|---|
|
Overall Survival (OS)
|
3.6 months
Interval 2.2 to 4.6
|
SECONDARY outcome
Timeframe: 6 monthsPatient-reported ascites symptoms were to be assessed using the patient questionnaire, Functional Assessment of Chronic Illness Therapy - Ascites Index (FACIT-AI). At 6 months following catumaxomab administration, the patient was requested to assess the severity of the following parameters during the past week using a 5-point scale with scores from "0 = not at all" to "4 = very much": anorexia, insomnia, decreased mobility, dyspnea, nausea, vomiting, abdominal pain, abdominal distention, fatigue, early satiety, urinary frequency, constipation, and emotional distress. For the parameters anorexia, insomnia, and decreased mobility, high scores mean good response, for the other parameters low scores mean good response.
Outcome measures
| Measure |
Catumaxomab
n=4 Participants
Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
|
|---|---|
|
Ascites Signs and Symptoms
I have good appetite
|
1.5 units on a scale
Interval 1.0 to 2.0
|
|
Ascites Signs and Symptoms
I am sleeping well
|
1.0 units on a scale
Interval 1.0 to 2.0
|
|
Ascites Signs and Symptoms
I am able to get around by myself
|
1.0 units on a scale
Interval 0.0 to 3.0
|
|
Ascites Signs and Symptoms
I have been short of breath
|
1.0 units on a scale
Interval 1.0 to 1.0
|
|
Ascites Signs and Symptoms
I have nausea
|
0.5 units on a scale
Interval 0.0 to 2.0
|
|
Ascites Signs and Symptoms
I have been vomiting
|
0.5 units on a scale
Interval 0.0 to 1.0
|
|
Ascites Signs and Symptoms
I have pain in my stomach area
|
1.0 units on a scale
Interval 1.0 to 1.0
|
|
Ascites Signs and Symptoms
I have swelling in my stomach area
|
1.0 units on a scale
Interval 0.0 to 2.0
|
|
Ascites Signs and Symptoms
I have lack of energy
|
2.0 units on a scale
Interval 1.0 to 3.0
|
|
Ascites Signs and Symptoms
When I eat, I seem to get full quickly
|
2.0 units on a scale
Interval 2.0 to 3.0
|
|
Ascites Signs and Symptoms
I urinate more frequently
|
0.0 units on a scale
Interval 0.0 to 2.0
|
|
Ascites Signs and Symptoms
I am bothered by constipation
|
1.0 units on a scale
Interval 0.0 to 1.0
|
|
Ascites Signs and Symptoms
I have been emotionally distressed
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 6 monthsAscites volume measurement were to be performed at screening (= prior to baseline), at baseline (= before start of therapy with catumaxomab) and during the 6-month follow-up period when the patient had recurrence of symptomatic ascites requiring therapeutic paracentesis. At each paracentesis, drainage to dryness was to be achieved and the exact volume was to be measured and documented.
Outcome measures
| Measure |
Catumaxomab
n=32 Participants
Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
|
|---|---|
|
Ascites Volume
prior to baseline (at screening)
|
2800 mL
Interval 50.0 to 8675.0
|
|
Ascites Volume
baseline (start of therapy)
|
2050 mL
Interval 60.0 to 5500.0
|
|
Ascites Volume
at puncture visit/ end of study (day 180)
|
1500 mL
Interval 0.0 to 3100.0
|
Adverse Events
Catumaxomab
Serious events: 24 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Catumaxomab
n=32 participants at risk
Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
18.8%
6/32 • Number of events 7 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
15.6%
5/32 • Number of events 7 • 6 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
12.5%
4/32 • Number of events 4 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Oesophagitis
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Peritonitis
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
General disorders
Extravasation
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
General disorders
Pyrexia
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
General disorders
Chills
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
General disorders
Device leakage
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
General disorders
Injection site reaction
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Infections and infestations
Abdominal abscess
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Infections and infestations
Bacteraemia
|
3.1%
1/32 • Number of events 2 • 6 months
|
|
Infections and infestations
Sepsis syndrome
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Infections and infestations
Septic shock
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
21.9%
7/32 • Number of events 7 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Catumaxomab
n=32 participants at risk
Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
31.2%
10/32 • Number of events 10 • 6 months
|
|
Cardiac disorders
Tachycardia
|
15.6%
5/32 • Number of events 6 • 6 months
|
|
Cardiac disorders
Sinus tachycardia
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Eye disorders
Diplopia
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
75.0%
24/32 • Number of events 39 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
75.0%
24/32 • Number of events 37 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
16/32 • Number of events 19 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
43.8%
14/32 • Number of events 15 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
28.1%
9/32 • Number of events 11 • 6 months
|
|
Gastrointestinal disorders
Abdominal distension
|
15.6%
5/32 • Number of events 6 • 6 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
15.6%
5/32 • Number of events 5 • 6 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.4%
3/32 • Number of events 5 • 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
General disorders
Fatigue
|
59.4%
19/32 • Number of events 21 • 6 months
|
|
General disorders
Pyrexia
|
59.4%
19/32 • Number of events 34 • 6 months
|
|
General disorders
Chills
|
43.8%
14/32 • Number of events 22 • 6 months
|
|
General disorders
Oedema peripheral
|
28.1%
9/32 • Number of events 12 • 6 months
|
|
General disorders
Asthenia
|
18.8%
6/32 • Number of events 6 • 6 months
|
|
General disorders
Catheter site pain
|
15.6%
5/32 • Number of events 6 • 6 months
|
|
General disorders
Oedema
|
12.5%
4/32 • Number of events 5 • 6 months
|
|
General disorders
Performance status decreased
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
General disorders
Catheter site erythema
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
General disorders
Chest pain
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
General disorders
Device leakage
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
General disorders
Extravasation
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Infections and infestations
Candidiasis
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Infections and infestations
Pneumonia
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Investigations
Blood alkaline phosphatase increased
|
12.5%
4/32 • Number of events 4 • 6 months
|
|
Investigations
Haemoglobin decreased
|
12.5%
4/32 • Number of events 5 • 6 months
|
|
Investigations
Weight decreased
|
12.5%
4/32 • Number of events 4 • 6 months
|
|
Investigations
Alanine aminotransferase increased
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Investigations
C-reactive protein increased
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Investigations
Haematocrit decreased
|
9.4%
3/32 • Number of events 4 • 6 months
|
|
Investigations
Protein total decreased
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Investigations
Blood albumin decreased
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Investigations
Blood chloride decreased
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Investigations
Blood magnesium decreased
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Investigations
Coagulation time prolonged
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Investigations
Oxygen saturation decreased
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Investigations
Urine output decreased
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Investigations
White blood cell count increased
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
34.4%
11/32 • Number of events 13 • 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
31.2%
10/32 • Number of events 11 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
21.9%
7/32 • Number of events 7 • 6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
18.8%
6/32 • Number of events 6 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
4/32 • Number of events 4 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Polydipsia
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
6/32 • Number of events 7 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
2/32 • Number of events 3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
25.0%
8/32 • Number of events 8 • 6 months
|
|
Nervous system disorders
Dizziness
|
12.5%
4/32 • Number of events 4 • 6 months
|
|
Nervous system disorders
Headache
|
9.4%
3/32 • Number of events 6 • 6 months
|
|
Nervous system disorders
Tremor
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Psychiatric disorders
Anxiety
|
15.6%
5/32 • Number of events 5 • 6 months
|
|
Psychiatric disorders
Confusional state
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Psychiatric disorders
Depression
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Psychiatric disorders
Insomnia
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Renal and urinary disorders
Proteinuria
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Renal and urinary disorders
Haematuria
|
6.2%
2/32 • Number of events 3 • 6 months
|
|
Renal and urinary disorders
Renal failure
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
28.1%
9/32 • Number of events 10 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
8/32 • Number of events 8 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
4/32 • Number of events 4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
18.8%
6/32 • Number of events 7 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.6%
5/32 • Number of events 5 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Vascular disorders
Hypotension
|
12.5%
4/32 • Number of events 5 • 6 months
|
|
Vascular disorders
Hypertension
|
6.2%
2/32 • Number of events 2 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Site may publish the results of the Study after such cooperative publication, or 1 year after Sponsor's final evaluation of all the Study data from all sites, whichever occurs first. Prior to any submission for publication, presentation, or communication of results or information arising from the Study, Investigator shall provide Fresenius Biotech at least 90 days for review and comment upon the manuscript or other material for such publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER