Trial Outcomes & Findings for A Trial Looking at the Use of Camostat in People Who Have Tested Positive for Coronavirus (COVID-19) (SPIKE-1) (NCT NCT04455815)

NCT ID: NCT04455815

Last Updated: 2023-12-11

Results Overview

Number of AEs and SAEs assessed as related to camostat by the Investigator.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Days 1 - 28

Results posted on

2023-12-11

Participant Flow

Trial participants were enrolled at four trial sites between 23 September 2020 and 23 June 2021.

Participant milestones

Participant milestones
Measure	Camostat Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days. Camostat: Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days.	Control Arm Patient to receive best supportive care.
Randomisation Phase STARTED	16	18
Randomisation Phase COMPLETED	15	18
Randomisation Phase NOT COMPLETED	1	0
Treatment Phase STARTED	15	18
Treatment Phase COMPLETED	13	16
Treatment Phase NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Camostat Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days. Camostat: Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days.	Control Arm Patient to receive best supportive care.
Randomisation Phase Adverse Event	1	0
Treatment Phase Adverse Event	0	1
Treatment Phase Hospital admission and treatment stopped in hospital	1	0
Treatment Phase Withdrawal by Subject	1	1

Baseline Characteristics

A Trial Looking at the Use of Camostat in People Who Have Tested Positive for Coronavirus (COVID-19) (SPIKE-1)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Camostat n=16 Participants Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days. Camostat: Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days.	Control Arm n=18 Participants Patient to receive best supportive care.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Asian / Asian British- Indian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian / Asian British- Pakistani	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White- English / Welsh / Scottish / Northern Irish / British	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized Any other White background	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United Kingdom	16 participants n=5 Participants	18 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: Days 1 - 28

Population: All enrolled patients who received at least one dose of camostat. As only participants in the Camostat Arm received camostat, this outcome measure is reported in the Camostat Arm only.

Number of AEs and SAEs assessed as related to camostat by the Investigator.

Outcome measures

Outcome measures
Measure	Camostat n=16 Participants Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days. Camostat: Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days.	Control Arm Patient to receive best supportive care.
Number of Camostat Related AEs and SAEs. Total AEs related to Camostat	11 Adverse Events	—
Number of Camostat Related AEs and SAEs. Total SAEs related to Camostat	0 Adverse Events	—

PRIMARY outcome

Timeframe: Days 1 - 28

Population: All enrolled patients who received at least one dose of camostat (or complete Day 1 of the control arm).

Number of AEs by Severity Grade (mild, moderate, severe)

Outcome measures

Outcome measures
Measure	Camostat n=16 Participants Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days. Camostat: Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days.	Control Arm n=18 Participants Patient to receive best supportive care.
Number of AEs by Severity Grade Total Severe AEs	2 Adverse Events	2 Adverse Events
Number of AEs by Severity Grade Total Mild AEs related to Camostat	5 Adverse Events	NA Adverse Events Patients in the control arm received best supportive care. These patients did not receive camostat and so a relatedness assessment to camostat is not applicable.
Number of AEs by Severity Grade Total Mild AEs	25 Adverse Events	25 Adverse Events
Number of AEs by Severity Grade Total Moderate AEs	10 Adverse Events	5 Adverse Events
Number of AEs by Severity Grade Total Moderate AEs related to Camostat	6 Adverse Events	NA Adverse Events Patients in the control arm received best supportive care. These patients did not receive camostat and so a relatedness assessment to camostat is not applicable.
Number of AEs by Severity Grade Total Severe AEs related to Camostat	0 Adverse Events	NA Adverse Events Patients in the control arm received best supportive care. These patients did not receive camostat and so a relatedness assessment to camostat is not applicable.

SECONDARY outcome

Timeframe: Days 7 and 14

Population: Analysis was not completed because no samples were collected for this analysis.

Maximum concentration (Cmax) of GBPA as assessed by population estimates from population PK analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 7 and 14

Population: Analysis was not completed because no samples were collected for this analysis

Time to maximum concentration (Tmax) of GBPA, as assessed by population estimates from population PK analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 7 and 14

Population: Analysis was not completed because no samples were collected for this analysis

Area under the curve (AUC) of GBPA, as assessed by population estimates from population PK analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1 - 28

Population: Analysis was not completed because no samples were collected for this analysis

Half-life (T1/2) of GBPA as assessed by population estimates from population PK analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1 - 28

Population: Treatment arm patients who received camostat for a minimum of five days, and control arm patients who completed up to Day 14 or came off trial at an earlier timepoint due to an endpoint (e.g. hospitalisation).

Number of patients who were recruited in community healthcare settings who were subsequently admitted to hospital due to COVID-19.

Outcome measures

Outcome measures
Measure	Camostat n=14 Participants Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days. Camostat: Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days.	Control Arm n=18 Participants Patient to receive best supportive care.
Number of Community Patients Admitted to Hospital Due to COVID-19	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Days 1 - 28

Number of days from Day 1 that each patient did not supplementary oxygen (median and range).

Outcome measures

Outcome measures
Measure	Camostat n=14 Participants Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days. Camostat: Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days.	Control Arm n=18 Participants Patient to receive best supportive care.
Number of Oxygen Free Days	28 Days Interval 4.0 to 28.0	28 Days Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: Days 1 - 28

Number of days from Day 1 that each patient did not require ventilation (median and range).

Outcome measures

Outcome measures
Measure	Camostat n=14 Participants Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days. Camostat: Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days.	Control Arm n=18 Participants Patient to receive best supportive care.
Number of Ventilator - Free Days	28 Days Interval 28.0 to 28.0	28 Days Interval 28.0 to 28.0

SECONDARY outcome

Timeframe: Days 1 - 28

Median time and range to worst point on the scale or deterioration of two points or more (from randomisation) on 9 point category ordinal scale. The scale was described in the protocol as follows: '0 - Uninfected, no clinical or virological evidence of infection, 1 - Ambulatory, no limitation of activities, 2 - Ambulatory, limitation of activities, 3 - Hospitalised - mild disease, no oxygen therapy, 4 - Hospitalised - mild disease, oxygen by mask or nasal prongs, 5 - Hospitalised - severe disease, non-invasive, ventilation or high-flow oxygen, 6 - Hospitalised - severe disease, intubation and mechanical ventilation, 7 - Hospitalised - severe disease, ventilation and additional organ support - vasopressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO), 8 - Death'

Outcome measures

Outcome measures
Measure	Camostat n=14 Participants Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days. Camostat: Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days.	Control Arm n=18 Participants Patient to receive best supportive care.
Time to Worst Point on the Scale or Deterioration of Two Points or More (From Randomisation) on 9 Point Category Ordinal Scale Ranging From '0 - Uninfected, no Clinical or Virological Evidence of Infection' to '8 - Death'	0 Days Interval 0.0 to 7.0	0 Days Interval 0.0 to 7.0

Adverse Events

Camostat

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

Control Arm

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Camostat n=16 participants at risk Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days. Camostat: Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days.	Control Arm n=18 participants at risk Patient to receive best supportive care.
Infections and infestations COVID-19 pneumonia	0.00% 0/16 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	5.6% 1/18 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	5.6% 1/18 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Investigations Oxygen saturation decreased	18.8% 3/16 • Number of events 3 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.

Other adverse events

Additional Information

Regulatory Affairs Manager

Cancer Research UK Centre for Drug Development

Phone: +44 203 4696878

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Camostat n=16 participants at risk Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days. Camostat: Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days.	Control Arm n=18 participants at risk Patient to receive best supportive care.
Investigations Alanine aminotransferase increased	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	11.1% 2/18 • Number of events 2 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Investigations Aspartate aminotransferase increased	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	5.6% 1/18 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Investigations Blood alkaline phosphatase increased	0.00% 0/16 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	5.6% 1/18 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Investigations Blood bilirubin increased	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Infections and infestations COVID-19 pneumonia	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	5.6% 1/18 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
General disorders Chest discomfort	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Gastrointestinal disorders Constipation	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Gastrointestinal disorders Diarrhoea	18.8% 3/16 • Number of events 3 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Gastrointestinal disorders Dry mouth	0.00% 0/16 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	5.6% 1/18 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Gastrointestinal disorders Dyspepsia	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/16 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	5.6% 1/18 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Investigations Fibrin D dimer increased	31.2% 5/16 • Number of events 5 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	38.9% 7/18 • Number of events 7 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Investigations Gamma-glutamyltransferase increased	12.5% 2/16 • Number of events 2 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	22.2% 4/18 • Number of events 4 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Investigations Haemoglobin decreased	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Metabolism and nutrition disorders Hypokalaemia	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Metabolism and nutrition disorders Hypophosphataemia	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	5.6% 1/18 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Psychiatric disorders Insomnia	0.00% 0/16 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	5.6% 1/18 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Infections and infestations Lower respiratory tract infection	12.5% 2/16 • Number of events 2 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	16.7% 3/18 • Number of events 3 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Infections and infestations Lower respiratory tract infection bacterial	0.00% 0/16 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	5.6% 1/18 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Gastrointestinal disorders Mouth ulceration	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Gastrointestinal disorders Nausea	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/16 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	5.6% 1/18 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Investigations Platelet count decreased	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Investigations Platelet count increased	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	5.6% 1/18 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/16 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	5.6% 1/18 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
General disorders Pyrexia	0.00% 0/16 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	5.6% 1/18 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Infections and infestations Sinusitis	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Gastrointestinal disorders Swollen tongue	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Cardiac disorders Tachycardia	0.00% 0/16 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	5.6% 1/18 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Investigations Troponin increased	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Infections and infestations Urinary tract infection	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Infections and infestations Viral rash	0.00% 0/16 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	5.6% 1/18 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.
Gastrointestinal disorders Vomiting	6.2% 1/16 • Number of events 1 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.	0.00% 0/18 • Safety data was collected from the time of informed consent until 28 days from Day 1.Patients who were hospitalised were followed up for up to 28 days after they were discharged. AE terms from vocabulary, MedDRA V24.0.