Trial Outcomes & Findings for A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL (NCT NCT01439347)
NCT ID: NCT01439347
Last Updated: 2021-09-09
Results Overview
Overall survival was defined as the time from the date of study randomization until death from any cause. Observations censored at the date of the last follow-up for subjects not known to have died.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
26 participants
Primary outcome timeframe
36 months
Results posted on
2021-09-09
Participant Flow
Participant milestones
| Measure |
Vincristine Sulfate Injection (VSI)
VSI dosed at 1.4 mg/m\^2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes.
|
Marqibo
Marqibo dosed at 2.25 mg/m\^2 (without any dose cap) as an IV infusion over 60 minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
13
|
Reasons for withdrawal
| Measure |
Vincristine Sulfate Injection (VSI)
VSI dosed at 1.4 mg/m\^2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes.
|
Marqibo
Marqibo dosed at 2.25 mg/m\^2 (without any dose cap) as an IV infusion over 60 minutes.
|
|---|---|---|
|
Overall Study
Death
|
10
|
9
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Sponsor Terminated Study
|
2
|
3
|
Baseline Characteristics
A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL
Baseline characteristics by cohort
| Measure |
Vincristine Sulfate Injection (VSI)
n=13 Participants
VSI dosed at 1.4 mg/m\^2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes.
|
Marqibo
n=13 Participants
Marqibo dosed at 2.25 mg/m\^2 (without any dose cap) as an IV infusion over 60 minutes.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
67 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Data for this outcome measure was not collected due to early termination of study.
Overall survival was defined as the time from the date of study randomization until death from any cause. Observations censored at the date of the last follow-up for subjects not known to have died.
Outcome measures
Outcome data not reported
Adverse Events
Vincristine Sulfate Injection (VSI)
Serious events: 8 serious events
Other events: 12 other events
Deaths: 10 deaths
Marqibo
Serious events: 12 serious events
Other events: 13 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Vincristine Sulfate Injection (VSI)
n=13 participants at risk
VSI dosed at 1.4 mg/m\^2 with a 2 mg dose cap as an IV infusion over 10 minutes.
|
Marqibo
n=13 participants at risk
Marqibo dosed at 2.25 mg/m\^2 (without any dose cap) as an IV infusion over 60 minutes.
|
|---|---|---|
|
Hepatobiliary disorders
Hepatic Failure
|
7.7%
1/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
7.7%
1/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Investigations
Blood Bilirubin Increased
|
15.4%
2/13 • 2 years
|
0.00%
0/13 • 2 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
30.8%
4/13 • 2 years
|
30.8%
4/13 • 2 years
|
|
Infections and infestations
Sepsis
|
30.8%
4/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Infections and infestations
Pneumonia
|
7.7%
1/13 • 2 years
|
23.1%
3/13 • 2 years
|
|
Infections and infestations
Septic Shock
|
15.4%
2/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
General disorders
Pyrexia
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Psychiatric disorders
Mental Status Changes
|
7.7%
1/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.00%
0/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Nervous system disorders
Metabolic Encephalopathy
|
0.00%
0/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Secretion Retention
|
0.00%
0/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.7%
1/13 • 2 years
|
0.00%
0/13 • 2 years
|
|
Cardiac disorders
Cardiac Arrest
|
7.7%
1/13 • 2 years
|
0.00%
0/13 • 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13 • 2 years
|
0.00%
0/13 • 2 years
|
|
General disorders
Asthenia
|
7.7%
1/13 • 2 years
|
0.00%
0/13 • 2 years
|
|
Infections and infestations
Aspergillus Infection
|
7.7%
1/13 • 2 years
|
0.00%
0/13 • 2 years
|
|
Infections and infestations
Cellulitis Orbital
|
7.7%
1/13 • 2 years
|
0.00%
0/13 • 2 years
|
|
Infections and infestations
Lung Infection
|
7.7%
1/13 • 2 years
|
0.00%
0/13 • 2 years
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
7.7%
1/13 • 2 years
|
0.00%
0/13 • 2 years
|
|
Investigations
Transaminases Increased
|
7.7%
1/13 • 2 years
|
0.00%
0/13 • 2 years
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • 2 years
|
0.00%
0/13 • 2 years
|
|
Nervous system disorders
Presyncope
|
7.7%
1/13 • 2 years
|
0.00%
0/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
7.7%
1/13 • 2 years
|
0.00%
0/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
7.7%
1/13 • 2 years
|
0.00%
0/13 • 2 years
|
Other adverse events
| Measure |
Vincristine Sulfate Injection (VSI)
n=13 participants at risk
VSI dosed at 1.4 mg/m\^2 with a 2 mg dose cap as an IV infusion over 10 minutes.
|
Marqibo
n=13 participants at risk
Marqibo dosed at 2.25 mg/m\^2 (without any dose cap) as an IV infusion over 60 minutes.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
69.2%
9/13 • 2 years
|
46.2%
6/13 • 2 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
46.2%
6/13 • 2 years
|
53.8%
7/13 • 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.8%
4/13 • 2 years
|
46.2%
6/13 • 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
53.8%
7/13 • 2 years
|
69.2%
9/13 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
76.9%
10/13 • 2 years
|
69.2%
9/13 • 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
69.2%
9/13 • 2 years
|
38.5%
5/13 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
61.5%
8/13 • 2 years
|
76.9%
10/13 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
38.5%
5/13 • 2 years
|
53.8%
7/13 • 2 years
|
|
General disorders
Asthenia
|
30.8%
4/13 • 2 years
|
53.8%
7/13 • 2 years
|
|
General disorders
Fatigue
|
53.8%
7/13 • 2 years
|
23.1%
3/13 • 2 years
|
|
General disorders
Oedema Peripheral
|
23.1%
3/13 • 2 years
|
69.2%
9/13 • 2 years
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
46.2%
6/13 • 2 years
|
46.2%
6/13 • 2 years
|
|
Investigations
Alanine Aminotransferase Increased
|
38.5%
5/13 • 2 years
|
53.8%
7/13 • 2 years
|
|
Investigations
Aspartate Aminotransferase Increased
|
38.5%
5/13 • 2 years
|
53.8%
7/13 • 2 years
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
38.5%
5/13 • 2 years
|
38.5%
5/13 • 2 years
|
|
Investigations
Blood Bilirubin Increased
|
23.1%
3/13 • 2 years
|
53.8%
7/13 • 2 years
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
30.8%
4/13 • 2 years
|
46.2%
6/13 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
38.5%
5/13 • 2 years
|
38.5%
5/13 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
38.5%
5/13 • 2 years
|
53.8%
7/13 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalelmia
|
46.2%
6/13 • 2 years
|
69.2%
9/13 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
38.5%
5/13 • 2 years
|
61.5%
8/13 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
46.2%
6/13 • 2 years
|
46.2%
6/13 • 2 years
|
|
Nervous system disorders
Headache
|
46.2%
6/13 • 2 years
|
38.5%
5/13 • 2 years
|
|
Psychiatric disorders
Anxiety
|
38.5%
5/13 • 2 years
|
38.5%
5/13 • 2 years
|
|
Psychiatric disorders
Insomnia
|
30.8%
4/13 • 2 years
|
46.2%
6/13 • 2 years
|
|
Vascular disorders
Hypotension
|
38.5%
5/13 • 2 years
|
53.8%
7/13 • 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
30.8%
4/13 • 2 years
|
23.1%
3/13 • 2 years
|
|
General disorders
Mucosal Inflammation
|
23.1%
3/13 • 2 years
|
38.5%
5/13 • 2 years
|
|
General disorders
Pyrexia
|
23.1%
3/13 • 2 years
|
23.1%
3/13 • 2 years
|
|
Investigations
Lipase Increased
|
30.8%
4/13 • 2 years
|
30.8%
4/13 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
30.8%
4/13 • 2 years
|
30.8%
4/13 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
30.8%
4/13 • 2 years
|
38.5%
5/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.8%
4/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
23.1%
3/13 • 2 years
|
30.8%
4/13 • 2 years
|
|
Nervous system disorders
Dizziness
|
23.1%
3/13 • 2 years
|
46.2%
6/13 • 2 years
|
|
Nervous system disorders
Neuropathy Peripheral
|
30.8%
4/13 • 2 years
|
30.8%
4/13 • 2 years
|
|
Nervous system disorders
Paraesthesia
|
30.8%
4/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Psychiatric disorders
Confusional State
|
15.4%
2/13 • 2 years
|
30.8%
4/13 • 2 years
|
|
Renal and urinary disorders
Renal Injury
|
7.7%
1/13 • 2 years
|
38.5%
5/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
23.1%
3/13 • 2 years
|
30.8%
4/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
23.1%
3/13 • 2 years
|
23.1%
3/13 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.4%
2/13 • 2 years
|
38.5%
5/13 • 2 years
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/13 • 2 years
|
23.1%
3/13 • 2 years
|
|
Cardiac disorders
Atrial Fibrillation
|
15.4%
2/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Cardiac disorders
Palpitations
|
7.7%
1/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Cardiac disorders
Tachycardia
|
7.7%
1/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Eye disorders
Vision Blurred
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13 • 2 years
|
30.8%
4/13 • 2 years
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
1/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Gastrointestinal disorders
Abdominal Distension
|
23.1%
3/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
General disorders
Chest Pain
|
7.7%
1/13 • 2 years
|
23.1%
3/13 • 2 years
|
|
General disorders
Chills
|
23.1%
3/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
General disorders
Gait Disturbance
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
General disorders
Malaise
|
7.7%
1/13 • 2 years
|
23.1%
3/13 • 2 years
|
|
General disorders
Oedema
|
15.4%
2/13 • 2 years
|
23.1%
3/13 • 2 years
|
|
Infections and infestations
Candida Infection
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Infections and infestations
Cellulitis
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/13 • 2 years
|
38.5%
5/13 • 2 years
|
|
Investigations
Transaminases Increased
|
7.7%
1/13 • 2 years
|
23.1%
3/13 • 2 years
|
|
Investigations
White Blood Cell Count Decreased
|
15.4%
2/13 • 2 years
|
23.1%
3/13 • 2 years
|
|
Investigations
Blood Phosphorus Increased
|
23.1%
3/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Investigations
Weight Decreased
|
15.4%
2/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Investigations
Alkaline Phosphatase Increased
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Investigations
Amylase Increased
|
23.1%
3/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Investigations
Blood Fibrinogen Decreased
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Metabolism and nutrition disorders
Acidosis
|
15.4%
2/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
7.7%
1/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
7.7%
1/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
15.4%
2/13 • 2 years
|
23.1%
3/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
15.4%
2/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
15.4%
2/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Nervous system disorders
Hypoaesthesia
|
23.1%
3/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/13 • 2 years
|
23.1%
3/13 • 2 years
|
|
Nervous system disorders
Syncope
|
15.4%
2/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Psychiatric disorders
Depression
|
15.4%
2/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Psychiatric disorders
Mental Status Changes
|
15.4%
2/13 • 2 years
|
23.1%
3/13 • 2 years
|
|
Psychiatric disorders
Agitation
|
7.7%
1/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
3/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.7%
1/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Alkalosis
|
7.7%
1/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
7.7%
1/13 • 2 years
|
23.1%
3/13 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • 2 years
|
23.1%
3/13 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
15.4%
2/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.7%
1/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Vascular disorders
Orthostatic Hypotension
|
15.4%
2/13 • 2 years
|
15.4%
2/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
30.8%
4/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
15.4%
2/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
15.4%
2/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Renal and urinary disorders
Dysuria
|
23.1%
3/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Renal and urinary disorders
Urinary Incontinence
|
7.7%
1/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Infections and infestations
Bacteraemia
|
23.1%
3/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Infections and infestations
Pneumonia
|
15.4%
2/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
General disorders
Chest Discomfort
|
15.4%
2/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
General disorders
Generalised Oedema
|
15.4%
2/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
General disorders
Pain
|
23.1%
3/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Injury, poisoning and procedural complications
Contusion
|
15.4%
2/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
7.7%
1/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
7.7%
1/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Gastrointestinal disorders
Oral Pain
|
7.7%
1/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
1/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Nervous system disorders
Hepatic Encephalopathy
|
7.7%
1/13 • 2 years
|
7.7%
1/13 • 2 years
|
|
Nervous system disorders
Lethargy
|
7.7%
1/13 • 2 years
|
7.7%
1/13 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place