Trial Outcomes & Findings for Revacept in Symptomatic Carotid Stenosis (NCT NCT01645306)

NCT ID: NCT01645306

Last Updated: 2021-01-28

Results Overview

The number of new diffusion weighted imaging (DWI) lesion(s) reported. (1 day after intervention compared to baseline).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 158 participants
• Primary outcome timeframe: 1 day post intervention
• Results posted on: 2021-01-28

Participant Flow

Participant milestones

Measure	Placebo Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Placebo: single intravenous injection	40 mg Revacept 40 mg Revacept in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection	120 mg Revacept 120 mg in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection
Overall Study STARTED	51	54	53
Overall Study COMPLETED	49	50	48
Overall Study NOT COMPLETED	2	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Revacept in Symptomatic Carotid Stenosis

Baseline characteristics by cohort

Measure	Placebo n=51 Participants Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Placebo: single intravenous injection	40 mg Revacept n=54 Participants 40 mg Revacept in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection	120 mg Revacept n=53 Participants 120 mg Revacept in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection	Total n=158 Participants Total of all reporting groups
Age, Continuous	67.3 years STANDARD_DEVIATION 10.25 • n=5 Participants	68.7 years STANDARD_DEVIATION 10.45 • n=7 Participants	68.4 years STANDARD_DEVIATION 9.82 • n=5 Participants	68.1 years STANDARD_DEVIATION 10.13 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants	38 Participants n=4 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	41 Participants n=7 Participants	36 Participants n=5 Participants	120 Participants n=4 Participants
Race/Ethnicity, Customized Ethnic Origin · African	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Ethnic Origin · Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Ethnic Origin · Caucasian	49 Participants n=5 Participants	52 Participants n=7 Participants	53 Participants n=5 Participants	154 Participants n=4 Participants
Region of Enrollment United Kingdom	14 participants n=5 Participants	18 participants n=7 Participants	18 participants n=5 Participants	50 participants n=4 Participants
Region of Enrollment Germany	37 participants n=5 Participants	36 participants n=7 Participants	35 participants n=5 Participants	108 participants n=4 Participants

PRIMARY outcome

Timeframe: 1 day post intervention

The number of new diffusion weighted imaging (DWI) lesion(s) reported. (1 day after intervention compared to baseline).

Outcome measures

Measure	Placebo n=51 Participants Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Placebo: single intravenous injection	40 mg Revacept n=54 Participants in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection	120 mg Revacept n=53 Participants in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection
New DWI Lesion(s)	1.2 Number of new lesions Standard Deviation 0.4	1.0 Number of new lesions Standard Deviation 0.3	0.6 Number of new lesions Standard Deviation 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days after IMP application

patients with any stroke or TIA occuring within 90 days after IMP application.

Outcome measures

Measure	Placebo n=51 Participants Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Placebo: single intravenous injection	40 mg Revacept n=54 Participants in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection	120 mg Revacept n=53 Participants in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection
Patients With Any Stroke or Transient Ischemic Attack (TIA)	6 Participants	6 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days after IMP application

patients with major bleedings occuring within 90 days after IMP application

Outcome measures

Measure	Placebo n=51 Participants Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Placebo: single intravenous injection	40 mg Revacept n=54 Participants in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection	120 mg Revacept n=53 Participants in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection
Major Bleedings	5 Participants	6 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 365 days after IMP application

patients with any stroke & TIA, myocardial infarction & percutaneous coronary intervention (PCI), death or bleeding within one year (365 days) after IMP application.

Outcome measures

Measure	Placebo n=51 Participants Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Placebo: single intravenous injection	40 mg Revacept n=54 Participants in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection	120 mg Revacept n=53 Participants in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection
Any Clinical Event	19 Number of Events	15 Number of Events	10 Number of Events

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 month (+/- 1 month) after IMP application

Anti-drug antibodies were measured at baseline and 3 month after IMP application.

Number of patients with positive anti-drug antibodies compared to baseline are counted.

Outcome measures

Measure	Placebo n=51 Participants Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Placebo: single intravenous injection	40 mg Revacept n=54 Participants in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection	120 mg Revacept n=53 Participants in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection
Anti-Drug Antibodies	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: ~ 365 days after IMP application (whole study period)

All adverse events were assessed during complete study period (~ 1 year after IMP application).

Outcome measures

Measure	Placebo n=51 Participants Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Placebo: single intravenous injection	40 mg Revacept n=54 Participants in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection	120 mg Revacept n=53 Participants in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection
Participants With Adverse Events (AEs) patients with drug related serious AEs	1 participants	4 participants	0 participants
Participants With Adverse Events (AEs) patients with adverse events	35 participants	41 participants	32 participants
Participants With Adverse Events (AEs) patients with drug related AEs	4 participants	10 participants	2 participants
Participants With Adverse Events (AEs) patients with serious AEs	17 participants	17 participants	15 participants
Participants With Adverse Events (AEs) patients with AE with fatal outcome events	0 participants	0 participants	1 participants

Adverse Events

Placebo

Serious events: 17 serious events

Other events: 18 other events

Deaths: 0 deaths

40 mg Revacept

Serious events: 17 serious events

Other events: 24 other events

Deaths: 0 deaths

120 mg Revacept

Serious events: 15 serious events

Other events: 17 other events

Deaths: 1 deaths

Serious adverse events

Measure	Placebo n=51 participants at risk Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Placebo: single intravenous injection	40 mg Revacept n=54 participants at risk in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection	120 mg Revacept n=53 participants at risk in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection
Vascular disorders Circulatory collapse	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Vascular disorders Hypertensive crisis	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Vascular disorders Hypotension	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Vascular disorders Ischemia	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Surgical and medical procedures Carotid Endarterectomy	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Surgical and medical procedures Chemotherapy	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Surgical and medical procedures Coronary angioplasty	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Surgical and medical procedures Coronary arterial stent insertion	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Surgical and medical procedures Skin lesion removal	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Surgical and medical procedures Vocal cordectomy	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glottis carcinoma	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma of skin	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
General disorders Asthenia	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
General disorders Chest discomfort	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
General disorders Chest pain	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Psychiatric disorders Panic attack	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Injury, poisoning and procedural complications Cerebral hyperperfusion syndrome	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Injury, poisoning and procedural complications Fall	3.9% 2/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Injury, poisoning and procedural complications Rib fracture	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Investigations Angiocardiogram	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Investigations Biopsy larynx	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Investigations Cardiac clearance	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Investigations Diffusion-weighted brain MRI	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Investigations Weight decrease	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Cardiac disorders Acute myocardial infarction	3.9% 2/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	3.7% 2/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	3.8% 2/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Cardiac disorders Angina pectoris	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Cardiac disorders Bradycardia	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Cardiac disorders Cardiac arrest	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Cardiac disorders Cardiac failure	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Cardiac disorders Cardiogenic shock	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Cardiac disorders Coronary artery disease	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Cardiac disorders Myocardial infarction	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Blood and lymphatic system disorders Anaemia	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Aphasia	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Ataxia	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Carotid artery stenosis	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Cerebellar infarction	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Cerebral haemorrhage	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Cerebral infarction	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	3.7% 2/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Cerebral ischemia	3.9% 2/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Cerebrovascular accident	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Clumsiness	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Dizziness	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Epilepsy	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Headache	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Hypoaesthesia	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Intracranial aneurysm	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Ischaemic stroke	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Loss of consciousness	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Parkinsonism	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Postictal paralysis	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Seizure	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Status epilepticus	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Stroke in evolution	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Subarachnoid haemorrhage	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Syncope	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Transient ischaemic attack	3.9% 2/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	7.5% 4/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Musculoskeletal and connective tissue disorders Intervertebral disc prorusion	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Metabolism and nutrition disorders Dehydration	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Metabolism and nutrition disorders Ketoacidosis	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Infections and infestations Lower respiratory tract infection	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Infections and infestations Pneumonia	3.9% 2/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Infections and infestations Pyelonephritis	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Infections and infestations Sepsis	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Infections and infestations Urinary tract infection	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.

Other adverse events

Measure	Placebo n=51 participants at risk Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Placebo: single intravenous injection	40 mg Revacept n=54 participants at risk in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection	120 mg Revacept n=53 participants at risk in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Revacept: single intravenous injection
Vascular disorders Hypertension	7.8% 4/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	3.7% 2/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	3.8% 2/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
General disorders Oedama peripheral	3.9% 2/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	9.3% 5/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	3.8% 2/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Injury, poisoning and procedural complications Fall	5.9% 3/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Injury, poisoning and procedural complications Procedural pain	5.9% 3/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	3.8% 2/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Investigations Cardiac murmur	5.9% 3/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Investigations Haemoglobin decreased	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	5.6% 3/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.9% 3/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Paraesthesia	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	5.7% 3/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Nervous system disorders Transient ischaemic attack	3.9% 2/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	7.5% 4/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Gastrointestinal disorders Nausea	2.0% 1/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	5.6% 3/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Gastrointestinal disorders Vomiting	0.00% 0/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	5.6% 3/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Musculoskeletal and connective tissue disorders Pain in extremity	3.9% 2/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	5.6% 3/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	3.8% 2/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Infections and infestations Pneumonia	7.8% 4/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	0.00% 0/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.
Infections and infestations Urinary tract infection	5.9% 3/51 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	1.9% 1/54 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.	3.8% 2/53 • Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.

Additional Information

Prof. Dr. Götz Münch, CRP & CEO

advanceCOR GmbH

Phone: +4989200020410

Email: muench@advancecor.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place