Trial Outcomes & Findings for Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections (NCT NCT02569541)

Last Updated: 2020-01-30

Results Overview

Number of participants in the intent to treat (ITT) analysis set who meet all the criteria for clinical success at the 6-Month Visit. Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

30 participants

Primary outcome timeframe

6 months after start of treatment

Results posted on

2020-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	CEM-102 (Sodium Fusidate) 1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy: * 6 months of treatment; or * 24 months of treatment (if continued on chronic suppressive therapy) sodium fusidate
Overall Study STARTED	30
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CEM-102 (Sodium Fusidate) n=30 Participants 1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy: * 6 months of treatment; or * 24 months of treatment (if continued on chronic suppressive therapy) sodium fusidate
Age, Continuous	61 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Height	174.5 cm STANDARD_DEVIATION 11.54 • n=5 Participants
Weight	87.4 kg STANDARD_DEVIATION 22.12 • n=5 Participants
BMI	28.7 kg/m2 STANDARD_DEVIATION 6.79 • n=5 Participants
Infection Type and Location Osteomyelitis	4 Participants n=5 Participants
Infection Type and Location Chronic septic arthritis - knee	1 Participants n=5 Participants
Infection Type and Location Prosthetic joint infection - knee	11 Participants n=5 Participants
Infection Type and Location Prosthetic joint infection - hip	4 Participants n=5 Participants
Infection Type and Location Prosthetic joint infection - shoulder	1 Participants n=5 Participants
Infection Type and Location Prosthetic joint infection - other	4 Participants n=5 Participants
Infection Type and Location Other orthopedic hardware	5 Participants n=5 Participants
Risk Factors for BJI Rheumatoid Arthritis	3 Participants n=5 Participants
Risk Factors for BJI Diabetes Mellitis	8 Participants n=5 Participants
Risk Factors for BJI Decubitis ulcers from Immobility	4 Participants n=5 Participants
Risk Factors for BJI Previous PJI in Another Anatomical Location	4 Participants n=5 Participants
Baseline Pathogen Staphylococcus aureus (MSSA)	12 Participants n=5 Participants
Baseline Pathogen Staphylococcus aureus (MRSA)	10 Participants n=5 Participants
Baseline Pathogen Staphylococcus epidermidis	4 Participants n=5 Participants
Baseline Pathogen coagulase-negative Staphylococcus	3 Participants n=5 Participants
Baseline Pathogen Corynebacterium striatum/simulans	2 Participants n=5 Participants
Baseline Pathogen Cutibacterium acnes	1 Participants n=5 Participants
Baseline Pathogen Streptococcus agalactiae	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after start of treatment

Population: ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study.

Outcome measures

Outcome measures
Measure	CEM-102 (Sodium Fusidate) n=30 Participants 1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy: * 6 months of treatment; or * 24 months of treatment (if continued on chronic suppressive therapy) sodium fusidate
Clinical Success at 6 Months Clinical Success	18 Participants
Clinical Success at 6 Months Clinical Failure	9 Participants
Clinical Success at 6 Months Indeterminate	3 Participants

SECONDARY outcome

Timeframe: Entire study period - up to 24 months

Population: Safety population - all enrolled subjects who received at least 1 dose of study drug.

Number of participants with TEAEs, SAEs, deaths, and discontinuations due to AEs. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.

Outcome measures

Outcome measures
Measure	CEM-102 (Sodium Fusidate) n=30 Participants 1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy: * 6 months of treatment; or * 24 months of treatment (if continued on chronic suppressive therapy) sodium fusidate
Safety and Tolerability TEAE Leading to Study Discontinuation	9 Participants
Safety and Tolerability TEAE Leading to Study Drug Discontinuation	12 Participants
Safety and Tolerability Treatment Emergent AE (TEAE)	29 Participants
Safety and Tolerability Severe TEAE	12 Participants
Safety and Tolerability TEAE Related to Study Drug	7 Participants
Safety and Tolerability TE Serious Adverse Event (SAE)	15 Participants
Safety and Tolerability TE SAE with outcome of death	0 Participants
Safety and Tolerability TE SAE Related to Study Drug	0 Participants
Safety and Tolerability TE SAE Leading to Study Discontinuation	7 Participants
Safety and Tolerability TE SAE Leading to Study Drug Discontinuation	9 Participants

SECONDARY outcome

Timeframe: 9 months after start of treatment

Population: ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study.

Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 9-Month Visit. Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia

Outcome measures

Outcome measures
Measure	CEM-102 (Sodium Fusidate) n=30 Participants 1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy: * 6 months of treatment; or * 24 months of treatment (if continued on chronic suppressive therapy) sodium fusidate
Clinical Success at 9 Months Clinical Success	15 Participants
Clinical Success at 9 Months Clinical Failure	11 Participants
Clinical Success at 9 Months Indeterminate	4 Participants

SECONDARY outcome

Timeframe: 12 months after start of treatment

Population: ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study.

Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 12-Month Visit. Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia

Outcome measures

Outcome measures
Measure	CEM-102 (Sodium Fusidate) n=30 Participants 1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy: * 6 months of treatment; or * 24 months of treatment (if continued on chronic suppressive therapy) sodium fusidate
Clinical Success at 12 Months Clinical Success	10 Participants
Clinical Success at 12 Months Clinical Failure	15 Participants
Clinical Success at 12 Months Indeterminate	5 Participants

SECONDARY outcome

Timeframe: 15 months after start of treatment

Population: ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study.

Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 15-Month Visit. Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia

Outcome measures

Outcome measures
Measure	CEM-102 (Sodium Fusidate) n=30 Participants 1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy: * 6 months of treatment; or * 24 months of treatment (if continued on chronic suppressive therapy) sodium fusidate
Clinical Success at 15 Months Clinical Success	8 Participants
Clinical Success at 15 Months Clinical Failure	17 Participants
Clinical Success at 15 Months Indeterminate	5 Participants

SECONDARY outcome

Timeframe: 18 months after start of treatment

Population: ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study.

Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 18-Month Visit. Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia

Outcome measures

Outcome measures
Measure	CEM-102 (Sodium Fusidate) n=30 Participants 1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy: * 6 months of treatment; or * 24 months of treatment (if continued on chronic suppressive therapy) sodium fusidate
Clinical Success at 18 Months Clinical Success	8 Participants
Clinical Success at 18 Months Clinical Failure	16 Participants
Clinical Success at 18 Months Indeterminate	6 Participants

SECONDARY outcome

Timeframe: 21 months after start of treatment

Population: ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study.

Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 21-Month Visit. Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia

Outcome measures

Outcome measures
Measure	CEM-102 (Sodium Fusidate) n=30 Participants 1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy: * 6 months of treatment; or * 24 months of treatment (if continued on chronic suppressive therapy) sodium fusidate
Clinical Success at 21 Months Clinical Success	6 Participants
Clinical Success at 21 Months Clinical Failure	17 Participants
Clinical Success at 21 Months Indeterminate	7 Participants

SECONDARY outcome

Timeframe: 24 months after start of treatment

Population: ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study.

Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 24-Month Visit. Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia

Outcome measures

Outcome measures
Measure	CEM-102 (Sodium Fusidate) n=30 Participants 1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy: * 6 months of treatment; or * 24 months of treatment (if continued on chronic suppressive therapy) sodium fusidate
Clinical Success at 24 Months Clinical Success	7 Participants
Clinical Success at 24 Months Clinical Failure	17 Participants
Clinical Success at 24 Months Indeterminate	6 Participants

Adverse Events

CEM-102 (Sodium Fusidate)

Serious events: 15 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CEM-102 (Sodium Fusidate) n=30 participants at risk 1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy: * 6 months of treatment; or * 24 months of treatment (if continued on chronic suppressive therapy) sodium fusidate
Cardiac disorders Atrial fibrillation	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Cardiac disorders Bradycardia	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Cardiac disorders Cardiac failure congestive	10.0% 3/30 • Number of events 3 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Gastrointestinal disorders Gastrointestinal haemorrhage	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Infections and infestations Arthritis infective	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Infections and infestations Device related infection	13.3% 4/30 • Number of events 4 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Infections and infestations Diverticulitis	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Infections and infestations Pneumonia	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Infections and infestations Pyelonephritis	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Infections and infestations Urinary tract infection	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Injury, poisoning and procedural complications Alcohol poisoning	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Injury, poisoning and procedural complications Overdose	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Injury, poisoning and procedural complications Synovial rupture	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Metabolism and nutrition disorders Hyperkalaemia	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Metabolism and nutrition disorders Hypervolaemia	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Nervous system disorders Encephalopathy	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Nervous system disorders Syncope	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Psychiatric disorders Alcohol withdrawal syndrome	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Renal and urinary disorders Acute kidney injury	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Skin and subcutaneous tissue disorders Yellow nail syndrome	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Surgical and medical procedures Abscess drainage	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Vascular disorders Haematoma	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Vascular disorders Hypertensive crisis	3.3% 1/30 • Number of events 1 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.

Other adverse events

Other adverse events
Measure	CEM-102 (Sodium Fusidate) n=30 participants at risk 1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy: * 6 months of treatment; or * 24 months of treatment (if continued on chronic suppressive therapy) sodium fusidate
Blood and lymphatic system disorders Anaemia	13.3% 4/30 • Number of events 4 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Eye disorders Vision blurred	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Gastrointestinal disorders Diarrhoea	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Gastrointestinal disorders Dyspepsia	10.0% 3/30 • Number of events 3 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Gastrointestinal disorders Large intestine polyp	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Gastrointestinal disorders Nausea	13.3% 4/30 • Number of events 4 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
General disorders Asthenia	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
General disorders Chest pain	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
General disorders Chills	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
General disorders Oedema peripheral	13.3% 4/30 • Number of events 4 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
General disorders Peripheral swelling	13.3% 4/30 • Number of events 4 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
General disorders Pyrexia	13.3% 4/30 • Number of events 4 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Infections and infestations Cellulitis	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Infections and infestations Urinary tract infection	30.0% 9/30 • Number of events 9 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Injury, poisoning and procedural complications Muscle strain	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Investigations International normalised ratio increased	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Investigations Weight decreased	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Metabolism and nutrition disorders Hyperkalaemia	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Metabolism and nutrition disorders Hypokalemia	10.0% 3/30 • Number of events 3 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 3/30 • Number of events 3 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Musculoskeletal and connective tissue disorders Joint swelling	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Psychiatric disorders Agitation	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Renal and urinary disorders Acute kidney injury	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Skin and subcutaneous tissue disorders Rash	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Vascular disorders Hypotension	6.7% 2/30 • Number of events 2 • 24 months Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.

Additional Information

Carl Kraus, MD (CEO)

Arrevus, Inc.

Phone: 9193665503

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor has the right to first publication of results, which would be made in conjunction with the PIs from all appropriate sites. Thereafter, PIs may publish results provided the PI submits the proposed publication to the Sponsor for review at least 60 days prior to the date of the proposed publication. The Sponsor may remove information that is considered confidential and/or proprietary and delay the proposed publication for an additional 60 days to enable filing of patent applications.
Publication restrictions are in place

Restriction type: OTHER