Trial Outcomes & Findings for Tofacitinib for Treatment of Moderate COVID-19 (NCT NCT04415151)

Last Updated: 2025-03-28

Results Overview

The primary objective of this study is to determine whether tofacitinib improves the clinical outcomes of patients with moderate SARS-CoV-2 infection as determined by the primary outcome measure: Proportion of subjects alive and not needing any form of mechanical ventilation, high flow oxygen, or ECMO by day 14.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

14 days

Results posted on

2025-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	Tofacitinib Tofacitinib will be administered in a dose of 10 mg PO BID until return to their clinical baseline (as defined by supplementary oxygen requirement), and then will continue to be administered at 5 mg PO BID for a total treatment duration of 14 days. Tofacitinib 10 mg: Tofacitinib will be administered in a dose of 10 mg twice daily by mouth (PO BID) until return to their clinical baseline (as defined by supplementary oxygen requirement), and then will continue to be administered at 5 mg PO BID for a total treatment duration of 14 days.	Placebo Matching placebo will be administered. Placebo: Matching placebo tablets will be administered.
Overall Study STARTED	13	11
Overall Study Day 1	13	11
Overall Study Day 2	13	9
Overall Study Day 3	13	9
Overall Study Day 4	12	9
Overall Study Day 5	12	8
Overall Study Day 6	11	8
Overall Study Day 7	11	8
Overall Study Day 8	9	5
Overall Study Day 9	6	5
Overall Study Day 10	5	5
Overall Study Day 11	5	4
Overall Study Day 12	5	4
Overall Study Day 13	4	4
Overall Study Day 14	3	4
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Tofacitinib Tofacitinib will be administered in a dose of 10 mg PO BID until return to their clinical baseline (as defined by supplementary oxygen requirement), and then will continue to be administered at 5 mg PO BID for a total treatment duration of 14 days. Tofacitinib 10 mg: Tofacitinib will be administered in a dose of 10 mg twice daily by mouth (PO BID) until return to their clinical baseline (as defined by supplementary oxygen requirement), and then will continue to be administered at 5 mg PO BID for a total treatment duration of 14 days.	Placebo Matching placebo will be administered. Placebo: Matching placebo tablets will be administered.
Overall Study Death	1	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Tofacitinib for Treatment of Moderate COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=11 Participants Placebo group	Tofacitinib n=13 Participants Tofacitinib group	Total n=24 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	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=7 Participants	0 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	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	11 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	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	13 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: All participants randomized and receiving at least 1 dose.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants taking Placebo with Usual Care.	Tofacitinib n=13 Participants Participants taking Tofacitinib with Usual Care.
Disease Severity	5 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to 14 days

Population: All participants randomized and receiving at least 1 dose.

Clinical improvement as measured by NIAID 8-point ordinal scale (i.e., 1 = death and 8 = Not hospitalized, no limitations on activities) at day 14. The scale is as follows: 1. Death 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized, no limitations on activities. Updated at the time of results entry, presented are the last clinical status for participants in the study (high scores are better outcomes).

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants taking Placebo with Usual Care.	Tofacitinib n=13 Participants Participants taking Tofacitinib with Usual Care.
Clinical Improvement (Last Measure) Death	1 Participants	1 Participants
Clinical Improvement (Last Measure) Hospitalized, requiring supplemental oxygen	3 Participants	1 Participants
Clinical Improvement (Last Measure) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)	0 Participants	1 Participants
Clinical Improvement (Last Measure) Hospitalized, on non-invasive ventilation or high flow oxygen devices	2 Participants	0 Participants
Clinical Improvement (Last Measure) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (CovID19/otherwise)	0 Participants	0 Participants
Clinical Improvement (Last Measure) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care	0 Participants	1 Participants
Clinical Improvement (Last Measure) Not hospitalized, limitation on activities and/or requiring home oxygen	5 Participants	9 Participants
Clinical Improvement (Last Measure) Not hospitalized, no limitations on activities	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 14 days

Population: All participants randomized and receiving at least 1 dose.

Clinical improvement as measured by NIAID 8-point ordinal scale (i.e., 1 = death and 8 = Not hospitalized, no limitations on activities) (days 3 through day 14): The scale is as follows: 1. Death 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized, no limitations on activities. Added at the time of results entry: this outcome presents those that improved at least 2 or more levels on the clinical scale (high scores are better outcomes).

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants taking Placebo with Usual Care.	Tofacitinib n=13 Participants Participants taking Tofacitinib with Usual Care.
Clinical Improvement (Improved Score)	5 Participants	9 Participants

SECONDARY outcome

Timeframe: Up to 14 days

Population: Of those that "recovered" within 14 days.

Time to recovery \[ Time Frame: Day 1 through Day 14\] (Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 2. Not hospitalized, limitation on activities and/or requiring home oxygen 3. Not hospitalized, no limitations on activities)

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants taking Placebo with Usual Care.	Tofacitinib n=10 Participants Participants taking Tofacitinib with Usual Care.
Time to Recovery	5.0 days Interval 3.0 to 8.0	5.0 days Interval 0.0 to 12.0

SECONDARY outcome

Timeframe: Up to 14 days

Population: Participants successfully follow up with.

Time to clinical improvement (defined as a 2-point increase on the NIAID 8-point ordinal scale (i.e., 1 = death and 8 = Not hospitalized, no limitations on activities). The scale is as follows: 1. Death 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized, no limitations on activities. Updated at the time of results entry, the follow up time frame was adjusted.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants taking Placebo with Usual Care.	Tofacitinib n=10 Participants Participants taking Tofacitinib with Usual Care.
Time to Clinical Improvement	5 days Interval 3.0 to 8.0	5 days Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: Up to 28 Days

Population: Participants (alive at end of 14 days) successfully followed up with.

Clinical status on the NIAID 8-point ordinal scale at day 30 The scale is as follows: 1. Death 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized, no limitations on activities. Updated at the time of results entry, the follow up time frame was adjusted.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants taking Placebo with Usual Care.	Tofacitinib n=10 Participants Participants taking Tofacitinib with Usual Care.
Clinical Status Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)	1 Participants	1 Participants
Clinical Status Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (CovID19/etc)	1 Participants	0 Participants
Clinical Status Not hospitalized, limitation on activities and/or requiring home oxygen	3 Participants	4 Participants
Clinical Status Not hospitalized, no limitations on activities	5 Participants	5 Participants

SECONDARY outcome

Timeframe: 60 Days

Population: Participants (alive at end of 14 days) successfully followed up with.

Clinical status on the NIAID 8-point ordinal scale at day 60 The scale is as follows: 1. Death 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized, no limitations on activities.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants taking Placebo with Usual Care.	Tofacitinib n=10 Participants Participants taking Tofacitinib with Usual Care.
Clinical Status Hospitalized, on non-invasive ventilation or high flow oxygen devices	1 Participants	1 Participants
Clinical Status Not hospitalized, limitation on activities and/or requiring home oxygen	4 Participants	1 Participants
Clinical Status Not hospitalized, no limitations on activities	3 Participants	8 Participants

SECONDARY outcome

Timeframe: 90 Days

Population: Participants (alive at end of 14 days) successfully followed up with.

Clinical status on the NIAID 8-point ordinal scale at day 90 The scale is as follows: 1. Death 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized, no limitations on activities.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Participants taking Placebo with Usual Care.	Tofacitinib n=11 Participants Participants taking Tofacitinib with Usual Care.
Clinical Status Hospitalized, on non-invasive ventilation or high flow oxygen devices	1 Participants	0 Participants
Clinical Status Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (CovID19/etc)	0 Participants	1 Participants
Clinical Status Not hospitalized, limitation on activities and/or requiring home oxygen	2 Participants	2 Participants
Clinical Status Not hospitalized, no limitations on activities	6 Participants	8 Participants

SECONDARY outcome

Timeframe: Up to 28 Days

Population: Participants successfully followed up with post study.

Mortality rate at day 30 (28 Days- updated at time of results entry). Presented are a count of those participants that expired (all-cause) through the 28 day follow up. This outcome includes counts of those that expired during the study period (see adverse events All-Cause Mortality).

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants taking Placebo with Usual Care.	Tofacitinib n=10 Participants Participants taking Tofacitinib with Usual Care.
Mortality	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 60 Days

Population: Participants successfully followed up with post study.

Mortality rate at day 60 (updated at time of results entry). Presented are a count of those participants that expired (all-cause) through the 60 day follow up. This outcome includes counts of those that expired during the study period (see adverse events All Cause Mortality).

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants taking Placebo with Usual Care.	Tofacitinib n=10 Participants Participants taking Tofacitinib with Usual Care.
Mortality	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 90 Days

Population: Participants successfully followed up with post study.

Mortality rate at day 90. Presented are a count of those participants that expired (all-cause) through the 90 day follow up. This outcome includes counts of those that expired during the study period (see adverse events All-Cause Mortality).

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Participants taking Placebo with Usual Care.	Tofacitinib n=11 Participants Participants taking Tofacitinib with Usual Care.
Mortality	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 14 Days

Population: All participants randomized and receiving at least 1 dose.

Proportion of patients requiring mechanical ventilatory support.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants taking Placebo with Usual Care.	Tofacitinib n=13 Participants Participants taking Tofacitinib with Usual Care.
Mechanical Ventilatory Support	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 14 Days

Population: Only those on invasive mechanical ventilation (days).

Duration of invasive mechanical ventilation (days).

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants Participants taking Placebo with Usual Care.	Tofacitinib n=2 Participants Participants taking Tofacitinib with Usual Care.
Mechanical Ventilatory Support Duration	2 days Interval 2.0 to 2.0	10.5 days Interval 10.0 to 11.0

SECONDARY outcome

Timeframe: Up to 14 Days

Population: All participants randomized and receiving at least 1 dose.

Invasive mechanical ventilation free days. The outcome was updated to present the number of participants that were without invasive mechanical ventilation while on study.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants taking Placebo with Usual Care.	Tofacitinib n=13 Participants Participants taking Tofacitinib with Usual Care.
Freedom From Mechanical Ventilation	10 Participants	11 Participants

SECONDARY outcome

Timeframe: Up to 14 days

Population: All participants randomized and receiving at least 1 dose.

Did the patient receive an intervention with additional immunomodulatory agent (i.e. IL-6 targeting therapy)? (y/n)

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants taking Placebo with Usual Care.	Tofacitinib n=13 Participants Participants taking Tofacitinib with Usual Care.
Additional Intervention Yes	0 Participants	0 Participants
Additional Intervention No	11 Participants	13 Participants

SECONDARY outcome

Timeframe: Day 7 (Day 5 to Day 9)

Population: All data collected on all participants

Change in SARS-CoV-2 viral titers during intervention. Upon entry of results, the time frame was updated to Day 7 to reflect the data collected in the terminated study. Nasopharyngeal (NP) swab were used and the visit window for Day 7 could include days between Day 5 to Day 9. Imputation for \< LLOQ: N gene: "\<200" is imputed to 2.0 log10 copies/mL (log10(200) - 0.3). ORF1ab gene: "\<3000" is imputed to 3.2 log10 copies/mL (log10(3000) - 0.3). Missing Data were not imputed.

Outcome measures

Outcome measures
Measure	Placebo n=7 Participants Participants taking Placebo with Usual Care.	Tofacitinib n=8 Participants Participants taking Tofacitinib with Usual Care.
Viral Titer SARS-CoV-2 Viral Load: ORF1ab Gene 7 DAYS	3.27 log10 (copies/mL) Standard Deviation 0.25	3.24 log10 (copies/mL) Standard Deviation 0.21
Viral Titer SARS-CoV-2 Viral Load: N Gene BASELINE	3.30 log10 (copies/mL) Standard Deviation 1.38	3.61 log10 (copies/mL) Standard Deviation 1.07
Viral Titer SARS-CoV-2 Viral Load: N Gene 7 DAYS	2.80 log10 (copies/mL) Standard Deviation 1.00	2.50 log10 (copies/mL) Standard Deviation 0.66
Viral Titer SARS-CoV-2 Viral Load: ORF1ab Gene BASELINE	3.70 log10 (copies/mL) Standard Deviation 0.79	3.92 log10 (copies/mL) Standard Deviation 0.82

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 14 days

Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. All adverse events are presented in the adverse event module.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 10 other events

Deaths: 1 deaths

Tofacitinib

Serious events: 2 serious events

Other events: 12 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=11 participants at risk Participants received placebo and usual care.	Tofacitinib n=13 participants at risk Participants received Tofacitinib and usual care.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	18.2% 2/11 • Number of events 2 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	7.7% 1/13 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
General disorders Death	9.1% 1/11 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	7.7% 1/13 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Infections and infestations Pneumonia	9.1% 1/11 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	0.00% 0/13 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days

Other adverse events

Additional Information

Hyung Chun, MD, FAHA

Yale School of Medicine

Phone: (203) 785-6012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo n=11 participants at risk Participants received placebo and usual care.	Tofacitinib n=13 participants at risk Participants received Tofacitinib and usual care.
Renal and urinary disorders Acute kidney injury	0.00% 0/11 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	7.7% 1/13 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/11 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	7.7% 1/13 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Investigations Alanine aminotransferase increased	36.4% 4/11 • Number of events 4 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	53.8% 7/13 • Number of events 7 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Blood and lymphatic system disorders Anaemia	27.3% 3/11 • Number of events 3 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	7.7% 1/13 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Investigations Aspartate aminotransferase increased	45.5% 5/11 • Number of events 5 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	46.2% 6/13 • Number of events 6 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Cardiac disorders Atrial fibrillation	0.00% 0/11 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	7.7% 1/13 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Infections and infestations Bacteraemia	9.1% 1/11 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	0.00% 0/13 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Gastrointestinal disorders Constipation	0.00% 0/11 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	7.7% 1/13 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Vascular disorders Embolism	9.1% 1/11 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	0.00% 0/13 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Infections and infestations Fungaemia	9.1% 1/11 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	0.00% 0/13 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Metabolism and nutrition disorders Hyperglycaemia	36.4% 4/11 • Number of events 4 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	15.4% 2/13 • Number of events 2 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Metabolism and nutrition disorders Hypoalbuminaemia	9.1% 1/11 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	0.00% 0/13 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Metabolism and nutrition disorders Hypokalaemia	9.1% 1/11 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	0.00% 0/13 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Respiratory, thoracic and mediastinal disorders Hypoxia	9.1% 1/11 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	15.4% 2/13 • Number of events 2 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Blood and lymphatic system disorders Leukocytosis	18.2% 2/11 • Number of events 2 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	15.4% 2/13 • Number of events 2 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Investigations Lymphocyte count decreased	9.1% 1/11 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	7.7% 1/13 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Gastrointestinal disorders Nausea	0.00% 0/11 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	7.7% 1/13 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
General disorders Non-cardiac chest pain	9.1% 1/11 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	0.00% 0/13 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Cardiac disorders Pericardial effusion	0.00% 0/11 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	7.7% 1/13 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Infections and infestations Pneumonia	9.1% 1/11 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	15.4% 2/13 • Number of events 2 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Respiratory, thoracic and mediastinal disorders Pneumothorax	9.1% 1/11 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	0.00% 0/13 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Cardiac disorders Sinus bradycardia	18.2% 2/11 • Number of events 2 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	15.4% 2/13 • Number of events 2 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Cardiac disorders Sinus tachycardia	9.1% 1/11 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	0.00% 0/13 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days
Gastrointestinal disorders Vomiting	0.00% 0/11 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days	7.7% 1/13 • Number of events 1 • All Other Adverse Events and Serious Adverse Event data were collected up to 14 days, All Cause Mortality data were collected up to 90 days