A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01176058
• Collaborator: (none)
• Enrollment: 17
• Locations: 7
• Arm: 1
• Duration (Months): 11
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

In the treatment of patients with candidemia and/or other forms of invasive candidiasis , Anidulafungin is at least as effective and safe as Fluconazole.

Condition or Disease	Intervention/Treatment	Phase
Candidemia	Drug: Anidulafungin/Fluconazole	Phase 3

Detailed Description

To support anidulafungin NDA in China Due to the challenges in subject recruitment resulting in protracted study course, Pfizer Inc. has decided to terminate trial A8851023 prematurely based on the recommendation by the senior management team on November 8, 2011. The decision to terminate the trial was not based on any safety concerns. All investigators were verbally informed by the study team since November 8, 2011 to stop the subject recruitment as soon as possible. All 17 enrolled subjects have been followed up on safety issues and no safety concerns were present by the data of these subjects.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: A Phase Iiib, Open-label, Randomized, Multi-center Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole, In The Treatment Of Subjects With Candidemia And/or Other Forms Of Invasive Candidiasis
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: open label	Drug: Anidulafungin/Fluconazole; Anidulafungin:IV,100 mg daily preceded by an initial 200 mg dose on Day 1, 14 - 42 days Fluconazole: IV/Oral, 400mg,QD,14 - 42 days

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT) [End of Intravenous Treatment (Up to Day 42)]

   Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were not available [N/A] for a participant with a successful clinical response). Failure - Any case that did not meet the criteria for success.

Secondary Outcome Measures

1. Percentage of Participants With Global Response at End of Treatment (EOT) [End of Treatment (Up to Day 42)]

   Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were N/A for a participant with a successful clinical response). Failure - Any case that did not meet the criteria for success.

2. Percentage of Participants With Clinical Response at EOIT [End of Intravenous Treatment (Up to Day 42)]

   Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.

3. Percentage of Participants With Clinical Response at EOT [End of Treatment (Up to Day 42)]

   Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.

4. Percentage of Participants With Clinical Response at Follow-Up [Post treatment follow-up visit (Up to Day 52)]

   Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.

5. Percentage of Participants With Microbiological Response at EOIT [End of Intravenous Treatment (Up to Day 42)]

   Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).

6. Percentage of Participants With Microbiological Response at EOT [End of Treatment (Up to Day 42)]

   Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).

7. Percentage of Participants With Microbiological Response at Follow-Up [Post treatment follow-up visit (Up to Day 52)]

   Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).

8. Number of Participants Who Died [Baseline to Day 52]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Presence of candidemia or invasive candidiasis.

• Presence of one or more of signs and symptoms of acute fungal infection.

Exclusion Criteria:

• Subjects who received greater than 48 hours of systemic antifungal treatment for the Candida infection for which they will be enrolled.

• Subjects with hypersensitivity to echinocandins or azole therapy or drug excipients.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanfang Hospital	Guangzhou	Guangdong	China	510515
2	Nanjing General Hospital of Nanjing Military Command/Respiratory Department	Nanjing	Jiangsu	China	210002
3	Changhai Hospital, Hemotology Department	Shanghai	Shanghai	China	200433
4	The First Affiliated Hospital of Medical School of Zhejiang University/Department of Hematology	Hangzhou	Zhejiang	China	310003
5	Sir run run shaw hospital, Affiliated with school of medicine, Zhejiang University	Hangzhou	Zhejiang	China	310016
6	Peking Union Medical College Hospital / Department of Infectious Disease	Beijing		China	100730
7	Institute of Antibiotics, Hua Shan Hospital, Fudan University	Shanghai		China	200040

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01176058
• Other Study ID Numbers: A8851023
• First Posted: Aug 5, 2010
• Last Update Posted: Oct 28, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Pfizer: Phase 3b; Efficacy and Safety evaluation of Anidulafungin; ICC
• Additional relevant MeSH terms: Candidiasis; Candidemia; Candidiasis, Invasive; Fluconazole; Anidulafungin

Study Results

Participant Flow

Arm/Group Title	Anidulafungin	Fluconazole
Arm/Group Description	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
Period Title: Overall Study
STARTED	9	8
COMPLETED	5	5
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Anidulafungin	Fluconazole	Total
Arm/Group Description	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.	Total of all reporting groups
Overall Participants	9	8	17
Age, Customized (participants) [Number]
Between 18 and 44 years	1 11.1%	4 50%	5 29.4%
Between 45 and 64 years	4 44.4%	2 25%	6 35.3%
More than 65 years	4 44.4%	2 25%	6 35.3%
Sex: Female, Male (Count of Participants)
Female	1 11.1%	3 37.5%	4 23.5%
Male	8 88.9%	5 62.5%	13 76.5%
Presence of Signs and Symptoms of Candidemia (participants) [Number]
Fever	7 77.8%	7 87.5%	14 82.4%
Hypothermia	0 0%	0 0%	0 0%
Tachycardia	3 33.3%	2 25%	5 29.4%
White blood cell count decreased	2 22.2%	0 0%	2 11.8%
White blood cell count increased	3 33.3%	1 12.5%	4 23.5%
White blood cell morphology abnormal	0 0%	1 12.5%	1 5.9%
Respiratory rate increased	2 22.2%	1 12.5%	3 17.6%
Partial pressure of carbon dioxide (PCO2) decrease	0 0%	1 12.5%	1 5.9%
Mechanical ventilation	1 11.1%	1 12.5%	2 11.8%
Swelling	1 11.1%	2 25%	3 17.6%
Feeling hot	4 44.4%	4 50%	8 47.1%
Localized erythema	1 11.1%	0 0%	1 5.9%
Purulence	1 11.1%	2 25%	3 17.6%
Other	2 22.2%	1 12.5%	3 17.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)
Description	Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were not available [N/A] for a participant with a successful clinical response). Failure - Any case that did not meet the criteria for success.
Time Frame	End of Intravenous Treatment (Up to Day 42)

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (MITT) population: participants had confirmed diagnosis of candidemia or other forms of invasive candidiasis, received at least 1 dose of study medication treatment, had at least 1 post-baseline efficacy evaluation. N=number of participants with evaluable data; participants with missing or indeterminate data set to Failure.

Arm/Group Title	Anidulafungin	Fluconazole
Arm/Group Description	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
Measure Participants	8	7
Success	62.50 694.4%	71.43 892.9%
Failure	37.50 416.7%	28.57 357.1%

2. Secondary Outcome

Title	Percentage of Participants With Global Response at End of Treatment (EOT)
Description	Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were N/A for a participant with a successful clinical response). Failure - Any case that did not meet the criteria for success.
Time Frame	End of Treatment (Up to Day 42)

Outcome Measure Data

Analysis Population Description

MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data set to Failure.

Arm/Group Title	Anidulafungin	Fluconazole
Arm/Group Description	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
Measure Participants	8	7
Success	62.50 694.4%	42.86 535.8%
Failure	37.50 416.7%	57.14 714.3%

3. Secondary Outcome

Title	Percentage of Participants With Clinical Response at EOIT
Description	Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.
Time Frame	End of Intravenous Treatment (Up to Day 42)

Outcome Measure Data

Analysis Population Description

MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.

Arm/Group Title	Anidulafungin	Fluconazole
Arm/Group Description	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
Measure Participants	8	7
Success	75.00 833.3%	71.43 892.9%
Failure	25.00 277.8%	28.57 357.1%

4. Secondary Outcome

Title	Percentage of Participants With Clinical Response at EOT
Description	Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.
Time Frame	End of Treatment (Up to Day 42)

Outcome Measure Data

Analysis Population Description

MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.

Arm/Group Title	Anidulafungin	Fluconazole
Arm/Group Description	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
Measure Participants	8	7
Success	75.00 833.3%	57.14 714.3%
Failure	25.00 277.8%	42.86 535.8%

5. Secondary Outcome

Title	Percentage of Participants With Clinical Response at Follow-Up
Description	Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.
Time Frame	Post treatment follow-up visit (Up to Day 52)

Outcome Measure Data

Analysis Population Description

MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.

Arm/Group Title	Anidulafungin	Fluconazole
Arm/Group Description	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
Measure Participants	8	7
Success	75.00 833.3%	57.14 714.3%
Failure	25.00 277.8%	42.86 535.8%

6. Secondary Outcome

Title	Percentage of Participants With Microbiological Response at EOIT
Description	Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).
Time Frame	End of Intravenous Treatment (Up to Day 42)

Outcome Measure Data

Analysis Population Description

MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set Failure.

Arm/Group Title	Anidulafungin	Fluconazole
Arm/Group Description	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
Measure Participants	8	7
Success	75.00 833.3%	85.71 1071.4%
Failure	25.00 277.8%	14.29 178.6%

7. Secondary Outcome

Title	Percentage of Participants With Microbiological Response at EOT
Description	Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).
Time Frame	End of Treatment (Up to Day 42)

Outcome Measure Data

Analysis Population Description

MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set to Failure.

Arm/Group Title	Anidulafungin	Fluconazole
Arm/Group Description	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
Measure Participants	8	7
Success	75.00 833.3%	57.14 714.3%
Failure	25.00 277.8%	42.86 535.8%

8. Secondary Outcome

Title	Percentage of Participants With Microbiological Response at Follow-Up
Description	Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).
Time Frame	Post treatment follow-up visit (Up to Day 52)

Outcome Measure Data

Analysis Population Description

MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set to Failure.

Arm/Group Title	Anidulafungin	Fluconazole
Arm/Group Description	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
Measure Participants	8	7
Success	62.50 694.4%	57.14 714.3%
Failure	37.50 416.7%	42.86 535.8%

9. Secondary Outcome

Title	Number of Participants Who Died
Time Frame	Baseline to Day 52

Outcome Measure Data

Analysis Population Description

Safety population: All participants who have received at least one dose of study medication.

Arm/Group Title	Anidulafungin	Fluconazole
Arm/Group Description	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
Measure Participants	9	8
Number [participants]	1 11.1%	0 0%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Anidulafungin		Fluconazole
Arm/Group Description	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.		IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
All Cause Mortality
	Anidulafungin		Fluconazole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Anidulafungin		Fluconazole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/9 (22.2%)		0/8 (0%)
General disorders
Disease progression	1/9 (11.1%)		0/8 (0%)
Respiratory, thoracic and mediastinal disorders
Respiratory failure	1/9 (11.1%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Anidulafungin		Fluconazole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/9 (66.7%)		6/8 (75%)
Cardiac disorders
Supraventricular tachycardia	1/9 (11.1%)		0/8 (0%)
Gastrointestinal disorders
Diarrhoea	0/9 (0%)		2/8 (25%)
Intestinal obsturction	1/9 (11.1%)		0/8 (0%)
Nausea	0/9 (0%)		1/8 (12.5%)
Vomiting	1/9 (11.1%)		2/8 (25%)
General disorders
Chest discomfort	0/9 (0%)		1/8 (12.5%)
Chills	1/9 (11.1%)		0/8 (0%)
Pyrexia	2/9 (22.2%)		1/8 (12.5%)
Hepatobiliary disorders
Hepatic function abnormal	1/9 (11.1%)		0/8 (0%)
Infections and infestations
Nasopharyngitis	0/9 (0%)		1/8 (12.5%)
Investigations
Aspartate aminotransferase increased	1/9 (11.1%)		0/8 (0%)
C-reactive protein increased	1/9 (11.1%)		0/8 (0%)
White blood cell count increased	2/9 (22.2%)		0/8 (0%)
Metabolism and nutrition disorders
Decreased appetite	0/9 (0%)		2/8 (25%)
Hypokalaemia	1/9 (11.1%)		1/8 (12.5%)
Hypoproteinaemia	2/9 (22.2%)		0/8 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/9 (11.1%)		0/8 (0%)
Psychiatric disorders
Insomnia	0/9 (0%)		1/8 (12.5%)
Renal and urinary disorders
Haematuria	1/9 (11.1%)		0/8 (0%)
Proteinuria	1/9 (11.1%)		0/8 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/9 (11.1%)		0/8 (0%)
Oropharyngeal discomfort	0/9 (0%)		1/8 (12.5%)
Skin and subcutaneous tissue disorders
Pruritus	1/9 (11.1%)		0/8 (0%)
Urticaria	1/9 (11.1%)		0/8 (0%)

Limitations/Caveats

Due to small enrollment, the per-protocol population was not determined, and analysis was performed on the mITT population.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.