Trial Outcomes & Findings for Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia (NCT NCT00509106)

NCT ID: NCT00509106

Last Updated: 2017-03-14

Results Overview

Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: * Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy * Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia * Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 622 participants
• Primary outcome timeframe: 8-15 days after last dose of study drug
• Results posted on: 2017-03-14

Participant Flow

Patients were recruited worldwide from July 2007 to August 2008

Patients were screened for up to 24 hours

Participant milestones

Measure	Ceftaroline Fosamil for Injection Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).	IV Ceftriaxone Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
Overall Study STARTED	315	307
Overall Study COMPLETED	284	278
Overall Study NOT COMPLETED	31	29

Reasons for withdrawal

Measure	Ceftaroline Fosamil for Injection Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).	IV Ceftriaxone Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
Overall Study Adverse Event	3	2
Overall Study Noncompliance	0	1
Overall Study At the request of sponsor/investigator	1	2
Overall Study Withdrew consent	4	8
Overall Study Lost to Follow-up	16	10
Overall Study Other	1	0
Overall Study Death	6	6

Baseline Characteristics

Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia

Baseline characteristics by cohort

Measure	Ceftaroline Fosamil for Injection n=315 Participants Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).	IV Ceftriaxone n=307 Participants Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).	Total n=622 Participants Total of all reporting groups
Age, Customized <65 years	183 participants n=93 Participants	173 participants n=4 Participants	356 participants n=27 Participants
Age, Customized >=65 years	132 participants n=93 Participants	134 participants n=4 Participants	266 participants n=27 Participants
Age, Continuous	59.0 years STANDARD_DEVIATION 17.0 • n=93 Participants	60.0 years STANDARD_DEVIATION 15.5 • n=4 Participants	59.5 years STANDARD_DEVIATION 16.3 • n=27 Participants
Sex: Female, Male Female	126 Participants n=93 Participants	105 Participants n=4 Participants	231 Participants n=27 Participants
Sex: Female, Male Male	189 Participants n=93 Participants	202 Participants n=4 Participants	391 Participants n=27 Participants

PRIMARY outcome

Timeframe: 8-15 days after last dose of study drug

Population: The MITTE Population consisted of all subjects in the MITT Population (all randomized subjects who received any amount of the study drug) in PORT Risk Class III or IV. The Pneumonia Outcomes Research Team (PORT) scale of CAP severity in which Risk Class I is associated with the lowest risk for mortality and Risk Class V represents the highest risk.

Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary

Failure: Any of the following:

• Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy
• Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia
• Death wherein pneumonia (ie,CABP) was considered causative

Indeterminate: Inability to determine an outcome

Outcome measures

Measure	Ceftaroline Fosamil for Injection n=315 Participants Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).	IV Ceftriaxone n=307 Participants Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population Clinical cure	235 participants	206 participants
Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population Clinical failure	47 participants	56 participants
Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population Indeterminate	7 participants	11 participants

PRIMARY outcome

Timeframe: 8-15 days after last dose of study drug

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Last day of study drug administration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8-15 days after last dose of study drug

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8-15 days after last dose of study drug

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8-15 days after last dose of study drug

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 21-35 days after last dose of study drug

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 21 to 35 days after last dose of study drug

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: first dose, throughout the treatment period, and up to the TOC visit

Outcome measures

Outcome data not reported

Adverse Events

Ceftaroline Fosamil for Injection

Serious events: 41 serious events

Other events: 67 other events

Deaths: 0 deaths

IV Ceftriaxone

Serious events: 39 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ceftaroline Fosamil for Injection n=315 participants at risk Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).	IV Ceftriaxone n=307 participants at risk Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.3% 4/315 • Number of events 4 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.98% 3/307 • Number of events 3 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.63% 2/315 • Number of events 2 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.63% 2/315 • Number of events 2 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Respiratory, thoracic and mediastinal disorders Pleurisy	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.65% 2/307 • Number of events 2 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Vascular disorders Cardiovascular insufficiency	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Vascular disorders Peripheral ischaemia	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Vascular disorders Hypertensive crisis	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Infections and infestations Sepsis	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Infections and infestations Septic shock	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Infections and infestations Endocarditis	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Infections and infestations Hepatitis C	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Infections and infestations Lung infection pseudomonal	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Infections and infestations Staphylococcal bactgeraemia	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Investigations Hepatic enzyme increased	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Metabolism and nutrition disorders Hypoglycaemia	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.95% 3/315 • Number of events 3 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.3% 4/315 • Number of events 4 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	1.6% 5/307 • Number of events 5 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Nervous system disorders Anoxic encephalopathy	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Nervous system disorders Convulsion	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Nervous system disorders Toxic encephalopathy	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Nervous system disorders Cerebrovascular accident	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Nervous system disorders Hemiplegia	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Renal and urinary disorders Renal failure	0.63% 2/315 • Number of events 2 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Renal and urinary disorders Hydronephrosis	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Reproductive system and breast disorders Epididymitis	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.3% 4/315 • Number of events 4 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	1.6% 5/307 • Number of events 5 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Cardiac disorders Cardiac arrest	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Cardiac disorders Cardiac failure congestive	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Cardiac disorders Cardiopulmonary failure	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Cardiac disorders Acute myocardial infarction	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Cardiac disorders Atrioventricular block complete	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Cardiac disorders Cardio-respiratory arrest	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Cardiac disorders Coronary artery disease	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Cardiac disorders Myocardial infarction	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Cardiac disorders Postinfarction angina	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Endocrine disorders Hypothyroidism	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Gastrointestinal disorders Duodenal ulcer	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Gastrointestinal disorders Gastric ulcer	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Gastrointestinal disorders Volvulus	0.00% 0/315 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Hepatobiliary disorders Hepatic failure	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Infections and infestations Pneumonia	2.2% 7/315 • Number of events 7 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	1.3% 4/307 • Number of events 4 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Infections and infestations Pyothorax	0.95% 3/315 • Number of events 3 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Infections and infestations Lung abscess	0.63% 2/315 • Number of events 2 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.98% 3/307 • Number of events 3 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Infections and infestations Urinary tract infection	0.63% 2/315 • Number of events 2 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.33% 1/307 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Infections and infestations Cellulitis	0.32% 1/315 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	0.00% 0/307 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug

Other adverse events

Measure	Ceftaroline Fosamil for Injection n=315 participants at risk Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).	IV Ceftriaxone n=307 participants at risk Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
Gastrointestinal disorders Diarrhea	3.8% 12/315 • Number of events 12 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	2.9% 9/307 • Number of events 9 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Gastrointestinal disorders Nausea	1.9% 6/315 • Number of events 6 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	2.0% 6/307 • Number of events 6 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Metabolism and nutrition disorders Hypokalemia	3.2% 10/315 • Number of events 10 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	1.6% 5/307 • Number of events 5 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Nervous system disorders Headache	3.5% 11/315 • Number of events 11 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	1.6% 5/307 • Number of events 5 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Psychiatric disorders Insomnia	3.2% 10/315 • Number of events 10 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	2.6% 8/307 • Number of events 8 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Vascular disorders Hypertension	2.5% 8/315 • Number of events 8 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	2.6% 8/307 • Number of events 8 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug
Vascular disorders Phlebitis	3.2% 10/315 • Number of events 10 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug	2.6% 8/307 • Number of events 8 All safety analysis was performed on the Safety Population, those subjects that had received any amount of actual study drug

Additional Information

Vice President, Clinical Sciences

Cerexa, Inc.

Phone: (510) 285-9200

Email: clinicaltrials@cerexa.com

Results disclosure agreements

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