Trial Outcomes & Findings for Safety, Tolerability and Preliminary Efficacy of FP-1201 in ALI and ARDS. Phase I/II (NCT NCT00789685)
NCT ID: NCT00789685
Last Updated: 2015-05-27
Results Overview
Treatment-emergent adverse events (TEAEs) in safety population
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
37 participants
Primary outcome timeframe
From first dose up until Day 28
Results posted on
2015-05-27
Participant Flow
Participant milestones
| Measure |
Interferon Beta
Interferon Beta
Interferon Beta administered intravenously daily for 6 days. Doses of 0.12 MIU, 1.2 MIU, 2.7 MIU or 6.0 MIU (dose escalation phase) or 2.7 MIU (dose expansion phase) were administered.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and Preliminary Efficacy of FP-1201 in ALI and ARDS. Phase I/II
Baseline characteristics by cohort
| Measure |
Safety Population
n=37 Participants
Safety population includes all patients who received at least one dose of study medication, and was used for summaries of demographic and other baseline characteristics
|
|---|---|
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Age, Continuous
|
52.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
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31 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South American
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
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37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose up until Day 28Population: Patients included in Safety population
Treatment-emergent adverse events (TEAEs) in safety population
Outcome measures
| Measure |
Safety Population
n=37 Participants
Safety population includes all patients who received at least one dose of study medication
|
|---|---|
|
Clinically Significant Treatment Emergent Events
TEAEs
|
37 Number of patients
|
|
Clinically Significant Treatment Emergent Events
Severe TEAEs
|
30 Number of patients
|
|
Clinically Significant Treatment Emergent Events
Serious TEAEs
|
22 Number of patients
|
|
Clinically Significant Treatment Emergent Events
Drug-Related TEAEs
|
20 Number of patients
|
|
Clinically Significant Treatment Emergent Events
Serious Drug-Related TEAEs
|
8 Number of patients
|
|
Clinically Significant Treatment Emergent Events
TEAEs leading to withdrawal
|
6 Number of patients
|
PRIMARY outcome
Timeframe: 28 days following commencement of therapyPopulation: Patients included in Safety population
The primary efficacy variable was all cause mortality at Day 28 following commencement of treatment
Outcome measures
| Measure |
Safety Population
n=37 Participants
Safety population includes all patients who received at least one dose of study medication
|
|---|---|
|
All Cause Mortality at Day 28
|
8.1 percentage of patients who died
|
SECONDARY outcome
Timeframe: 6 months following commencement of therapyPopulation: Number of patients whose survival status at 6 months was known
A long-term secondary efficacy variable was all cause mortality at 6 months following commencement of treatment
Outcome measures
| Measure |
Safety Population
n=36 Participants
Safety population includes all patients who received at least one dose of study medication
|
|---|---|
|
All Cause Mortality Rate at 6 Months
|
11.1 percentage of patients who died
|
Adverse Events
Safety Population
Serious events: 22 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Population
n=37 participants at risk
Safety population includes all patients who received at least one dose of study medication
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytosis
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Cardiac disorders
Cardiopulmonary Failure
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Cardiac disorders
Cardiac Arrest
|
5.4%
2/37 • Number of events 4 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Sepsis
|
2.7%
1/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Cardiac disorders
Pericardial Effusion
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
8.1%
3/37 • Number of events 3 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
General disorders
Pyrexia
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
General disorders
Chills
|
2.7%
1/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Cardiac disorders
Sinus Tachycardia
|
2.7%
1/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Investigations
Haemoglobin Decreased
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Klebsiella Sepsis
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Immune system disorders
Hypersensitivity
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Clostridial Infection
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.1%
3/37 • Number of events 4 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
General disorders
Multi-Organ Failure
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Septic Shock
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Blood and lymphatic system disorders
Hyperbilirubinaemia
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Investigations
Alanine Aminotransferase Increased
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Investigations
Platelet Count Decreased
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Respiratory Tract Infection
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
Other adverse events
| Measure |
Safety Population
n=37 participants at risk
Safety population includes all patients who received at least one dose of study medication
|
|---|---|
|
Investigations
Haemoglobin Decreased
|
32.4%
12/37 • Number of events 22 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Investigations
Electrocardiogram T Wave Inversion
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Investigations
Nasogastric Output High
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Investigations
Blood Sodium Increased
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Investigations
Electrocardiogram QT Prolonged
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Investigations
Oxygen Saturation Decreased
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Investigations
Troponin T Increased
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
24.3%
9/37 • Number of events 35 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
24.3%
9/37 • Number of events 11 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Gastrointestinal disorders
Constipation
|
24.3%
9/37 • Number of events 10 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
8.1%
3/37 • Number of events 3 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Gastrointestinal disorders
Nausea
|
8.1%
3/37 • Number of events 3 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Gastrointestinal disorders
Faecal volume increased
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Gastrointestinal disorders
Haematochezia
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Gastrointestinal disorders
Oral pain
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Candidiasis
|
10.8%
4/37 • Number of events 5 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Clostridial Infection
|
8.1%
3/37 • Number of events 3 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Cellulitis
|
8.1%
3/37 • Number of events 3 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Sepsis
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Oral Candidiasis
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Staphylococcal Infection
|
2.7%
1/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Abdominal Sepsis
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Bacterial Infection
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Empyema
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Escherichia Bacteraemia
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Escherichia Infection
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Infection
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Klebsiella Infection
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Lung Infection Pseudomonal
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Pneumonia
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Pneumonia Cytomegaloviral
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Salmonellosis
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Urinary Tract Infection Fungal
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Infections and infestations
Wound Infection
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Psychiatric disorders
Insomnia
|
27.0%
10/37 • Number of events 11 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Psychiatric disorders
Agitation
|
13.5%
5/37 • Number of events 6 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Psychiatric disorders
Confusional State
|
10.8%
4/37 • Number of events 5 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Psychiatric disorders
Delirium
|
10.8%
4/37 • Number of events 4 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Psychiatric disorders
Anxiety
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Psychiatric disorders
Depression
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Psychiatric disorders
Post-Traumatic Stress Disorder
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
General disorders
Pyrexia
|
29.7%
11/37 • Number of events 17 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
General disorders
Hyperpyrexia
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
General disorders
Pain
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
General disorders
Fatigue
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
General disorders
Generalised Oedema
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
General disorders
Influenza Like Illness
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Cardiac disorders
Tachycardia
|
10.8%
4/37 • Number of events 8 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Cardiac disorders
Atrial Fibrillation
|
10.8%
4/37 • Number of events 4 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Cardiac disorders
Arrhythmia
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Cardiac disorders
Bradycardia
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Cardiac disorders
Right Ventricular Hypertrophy
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
10.8%
4/37 • Number of events 6 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Metabolism and nutrition disorders
Oedema Peripheral
|
8.1%
3/37 • Number of events 3 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Metabolism and nutrition disorders
Acidosis
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Metabolism and nutrition disorders
Alkalosis
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Metabolism and nutrition disorders
Metabolic Alkalosis
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.4%
2/37 • Number of events 3 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Respiratory, thoracic and mediastinal disorders
Increased Bronchial Secretion
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Cavitation
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Gas Exchange Disorder
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Blood and lymphatic system disorders
Anaemia
|
10.8%
4/37 • Number of events 6 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Vascular disorders
Hypertension
|
5.4%
2/37 • Number of events 7 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Vascular disorders
Haemorrhage
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Vascular disorders
Post Procedural Haemorrhage
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Vascular disorders
Cerebral Infarction
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Vascular disorders
Deep Vein Thrombosis
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Vascular disorders
Extremity Necrosis
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Vascular disorders
Vasculitis
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Renal and urinary disorders
Renal Impairment
|
10.8%
4/37 • Number of events 6 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Renal and urinary disorders
Polyuria
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Renal and urinary disorders
Renal Failure
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Renal and urinary disorders
Renal Pain
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Nervous system disorders
Headache
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Nervous system disorders
Convulsion
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Nervous system disorders
Partial Seizures
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Nervous system disorders
Peroneal Nerve Palsy
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Nervous system disorders
Tremor
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Injury, poisoning and procedural complications
Collapse of Lung
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Injury, poisoning and procedural complications
Gastrointestinal Stoma Complication
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Injury, poisoning and procedural complications
Subcutaneous Emphysema
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Reproductive system and breast disorders
Genital Swelling
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Reproductive system and breast disorders
Penile Oedema
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Reproductive system and breast disorders
Scrotal Oedema
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Reproductive system and breast disorders
Scrotal Swelling
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Immune system disorders
Cytokine Release Syndrome
|
2.7%
1/37 • Number of events 3 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Musculoskeletal and connective tissue disorders
Critical Illness Polyneuropathy
|
5.4%
2/37 • Number of events 2 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Musculoskeletal and connective tissue disorders
Rib Fracture
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Eye disorders
Herpes Simplex Ophthalmic
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Eye disorders
Vitreous Floaters
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
|
Ear and labyrinth disorders
Deafness Unilateral
|
2.7%
1/37 • Number of events 1 • Over the course of the study (Days 1 - 28) and at withdrawal
Adverse Events (AEs) were reviewed and documented from the time the first dose was given up until Day 28. AEs were also reviewed and documented at the withdrawal visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Review by sponsor of related publication \& communications
- Publication restrictions are in place
Restriction type: OTHER