Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma (ARCC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00065468
First received: July 24, 2003
Last updated: September 24, 2012
Last verified: September 2012
Results First Received: March 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Carcinoma, Renal Cell
Kidney Neoplasms
Interventions: Drug: Interferon Alfa
Drug: CCI-779
Drug: Interferon Alfa and CCI-779

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Interferon Alfa Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
Temsirolimus Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
Interferon Alfa and Temsirolimus Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal

Participant Flow:   Overall Study
    Interferon Alfa     Temsirolimus     Interferon Alfa and Temsirolimus  
STARTED     207     209     210  
Received Treatment     200     208     208  
COMPLETED     0     0     0  
NOT COMPLETED     207     209     210  
Death                 172                 169                 171  
Withdrawal by Subject                 3                 4                 5  
Lost to Follow-up                 5                 3                 2  
Discontinuation of study by Sponsor                 13                 9                 13  
Disease progression                 0                 0                 1  
Unspecified                 14                 24                 18  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Interferon Alfa Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
Temsirolimus Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
Interferon Alfa and Temsirolimus Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
Total Total of all reporting groups

Baseline Measures
    Interferon Alfa     Temsirolimus     Interferon Alfa and Temsirolimus     Total  
Number of Participants  
[units: participants]
  207     209     210     626  
Age  
[units: years]
Mean ± Standard Deviation
  59.2  ± 10.4     58.7  ± 10.0     59.3  ± 9.8     59.1  ± 10.1  
Gender  
[units: participants]
       
Female     59     70     65     194  
Male     148     139     145     432  



  Outcome Measures
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1.  Primary:   Overall Survival (OS)   [ Time Frame: Baseline up to Month 80 ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline, monthly until tumor progression or death (up to Month 80) ]

3.  Secondary:   Percentage of Participants With Objective Response   [ Time Frame: Baseline, every 2 months until tumor progression or death (up to Month 80) ]

4.  Secondary:   Percentage of Participants With Clinical Benefit   [ Time Frame: Baseline, every 2 months until tumor progression or death (up to Month 80) ]

5.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline, every month until tumor progression or death (up to Month 80) ]

6.  Secondary:   Time to Treatment Failure (TTF)   [ Time Frame: Baseline, every month until tumor progression or death (up to Month 80) ]

7.  Secondary:   Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)   [ Time Frame: Baseline to Month 80 ]

8.  Secondary:   European Quality of Life Health Questionnaire (EQ-5D) - Index Score   [ Time Frame: Baseline ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description The same event may appear as both an AE and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.

Reporting Groups
  Description
Interferon Alfa Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
Temsirolimus Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
Interferon Alfa and Temsirolimus Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal

Serious Adverse Events
    Interferon Alfa     Temsirolimus     Interferon Alfa and Temsirolimus  
Total, serious adverse events        
# participants affected / at risk     99/200 (49.50%)     82/208 (39.42%)     122/208 (58.65%)  
Blood and lymphatic system disorders        
ANEMIA * 1 [3]      
# participants affected / at risk     12/200 (6.00%)     11/208 (5.29%)     20/208 (9.62%)  
THROMBOCYTOPENIA * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     4/208 (1.92%)  
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
DISSEMINATED INTRAVASCULAR COAGULATION * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
FIBRINOGEN INCREASED * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
THROMBIN TIME PROLONGED * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
Cardiac disorders        
ATRIAL FIBRILLATION * 1 [4]      
# participants affected / at risk     2/200 (1.00%)     2/208 (0.96%)     1/208 (0.48%)  
CONGESTIVE HEART FAILURE * 1      
# participants affected / at risk     1/200 (0.50%)     2/208 (0.96%)     0/208 (0.00%)  
DEEP VEIN THROMBOSIS * 1      
# participants affected / at risk     1/200 (0.50%)     2/208 (0.96%)     0/208 (0.00%)  
HYPERTENSION * 1      
# participants affected / at risk     1/200 (0.50%)     2/208 (0.96%)     2/208 (0.96%)  
MYOCARDIAL INFARCT * 1      
# participants affected / at risk     2/200 (1.00%)     2/208 (0.96%)     1/208 (0.48%)  
PULMONARY EMBOLUS * 1      
# participants affected / at risk     1/200 (0.50%)     2/208 (0.96%)     3/208 (1.44%)  
CEREBROVASCULAR ACCIDENT * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     1/208 (0.48%)  
HEART FAILURE * 1      
# participants affected / at risk     1/200 (0.50%)     1/208 (0.48%)     2/208 (0.96%)  
INTRACRANIAL HEMORRHAGE 0 * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
PERICARDIAL EFFUSION * 1      
# participants affected / at risk     1/200 (0.50%)     1/208 (0.48%)     0/208 (0.00%)  
PERIPHERAL GANGRENE * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
SYNCOPE * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
TACHYCARDIA SINUS * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
ANGINA PECTORIS * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
CARDIOMYOPATHY * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
CEREBRAL HEMORRHAGE * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
CEREBRAL ISCHEMIA * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
CEREBROVASCULAR DISORDER * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
HEART ARREST * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
HEMORRHAGE * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     2/208 (0.96%)  
HYPOTENSION * 1      
# participants affected / at risk     2/200 (1.00%)     0/208 (0.00%)     2/208 (0.96%)  
HYPOVOLEMIA * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
POSTURAL HYPOTENSION 1 * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
SHOCK * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
THROMBOSIS * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
VASCULAR DISORDER * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
Endocrine disorders        
DIABETES MELLITUS * 1 [5]      
# participants affected / at risk     0/200 (0.00%)     2/208 (0.96%)     0/208 (0.00%)  
THYROID CARCINOMA * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
Eye disorders        
CATARACT SPECIFIED * 1 [6]      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     2/208 (0.96%)  
DIPLOPIA * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
Gastrointestinal disorders        
STOMATITIS * 1 [7]      
# participants affected / at risk     0/200 (0.00%)     3/208 (1.44%)     4/208 (1.92%)  
GASTROINTESTINAL HEMORRHAGE * 1      
# participants affected / at risk     0/200 (0.00%)     2/208 (0.96%)     0/208 (0.00%)  
NAUSEA * 1      
# participants affected / at risk     3/200 (1.50%)     2/208 (0.96%)     2/208 (0.96%)  
VOMITING * 1      
# participants affected / at risk     3/200 (1.50%)     2/208 (0.96%)     1/208 (0.48%)  
DIARRHEA * 1      
# participants affected / at risk     1/200 (0.50%)     1/208 (0.48%)     6/208 (2.88%)  
GASTROINTESTINAL DISORDER * 1      
# participants affected / at risk     1/200 (0.50%)     1/208 (0.48%)     0/208 (0.00%)  
ILEUS * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     1/208 (0.48%)  
INTESTINAL PERFORATION * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
MUCOSITIS * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     2/208 (0.96%)  
ANOREXIA * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     3/208 (1.44%)  
COLITIS * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
CONSTIPATION * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     1/208 (0.48%)  
GASTROENTERITIS * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
HEMATEMESIS * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
HEMORRHAGIC GASTRITIS * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
HEPATIC FAILURE * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
HEPATITIS * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
INTESTINAL OBSTRUCTION * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     1/208 (0.48%)  
LIVER FATTY DEPOSIT * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
MELENA * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
PROCTITIS * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
RECTAL HEMORRHAGE * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
General disorders        
ABDOMINAL PAIN * 1 [8]      
# participants affected / at risk     1/200 (0.50%)     5/208 (2.40%)     4/208 (1.92%)  
BACK PAIN * 1      
# participants affected / at risk     2/200 (1.00%)     4/208 (1.92%)     1/208 (0.48%)  
CARCINOMA * 1      
# participants affected / at risk     9/200 (4.50%)     4/208 (1.92%)     13/208 (6.25%)  
ASTHENIA * 1      
# participants affected / at risk     7/200 (3.50%)     3/208 (1.44%)     10/208 (4.81%)  
FEVER * 1      
# participants affected / at risk     3/200 (1.50%)     3/208 (1.44%)     8/208 (3.85%)  
ASCITES * 1      
# participants affected / at risk     1/200 (0.50%)     2/208 (0.96%)     0/208 (0.00%)  
GENERAL PHYSICAL HEALTH DETERIORATION * 1      
# participants affected / at risk     0/200 (0.00%)     2/208 (0.96%)     1/208 (0.48%)  
PAIN * 1      
# participants affected / at risk     0/200 (0.00%)     2/208 (0.96%)     3/208 (1.44%)  
ABSCESS * 1      
# participants affected / at risk     1/200 (0.50%)     1/208 (0.48%)     0/208 (0.00%)  
ACCIDENTAL INJURY * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     3/208 (1.44%)  
CHEST PAIN * 1      
# participants affected / at risk     1/200 (0.50%)     1/208 (0.48%)     1/208 (0.48%)  
HERNIA * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
INFECTION * 1      
# participants affected / at risk     1/200 (0.50%)     1/208 (0.48%)     1/208 (0.48%)  
INFLAMMATION * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
MALAISE * 1      
# participants affected / at risk     1/200 (0.50%)     1/208 (0.48%)     0/208 (0.00%)  
MEDICATION ERROR * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
NEOPLASM * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
OVERDOSE * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     2/208 (0.96%)  
PELVIC PAIN * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
SEPSIS * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     3/208 (1.44%)  
ABDOMINAL SYNDROME ACUTE * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
ACCIDENTAL OVERDOSE * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
ALLERGIC REACTION * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     1/208 (0.48%)  
CELLULITIS * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     3/208 (1.44%)  
CHILLS * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
FLU SYNDROME * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
GENERALIZED EDEMA * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
NECK PAIN * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     2/208 (0.96%)  
TUMOR LYSIS SYNDROME * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
DEVICE MALFUNCTION * 1 [9]      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     2/208 (0.96%)  
Metabolism and nutrition disorders        
HYPERGLYCEMIA * 1 [10]      
# participants affected / at risk     0/200 (0.00%)     6/208 (2.88%)     0/208 (0.00%)  
DEHYDRATION * 1      
# participants affected / at risk     7/200 (3.50%)     5/208 (2.40%)     10/208 (4.81%)  
CREATININE INCREASED * 1      
# participants affected / at risk     0/200 (0.00%)     3/208 (1.44%)     1/208 (0.48%)  
HYPERCALCEMIA * 1      
# participants affected / at risk     2/200 (1.00%)     3/208 (1.44%)     4/208 (1.92%)  
HYPERKALEMIA * 1      
# participants affected / at risk     2/200 (1.00%)     2/208 (0.96%)     2/208 (0.96%)  
ALKALINE PHOSPHATASE INCREASED * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
BUN INCREASED * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
HYPERLIPEMIA * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     3/208 (1.44%)  
HYPOCALCEMIA * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     2/208 (0.96%)  
HYPOKALEMIA * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
HYPONATREMIA * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     1/208 (0.48%)  
PERIPHERAL EDEMA * 1      
# participants affected / at risk     1/200 (0.50%)     1/208 (0.48%)     1/208 (0.48%)  
SGOT INCREASED * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
BILIRUBINEMIA * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
CACHEXIA * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     2/208 (0.96%)  
FAILURE TO THRIVE * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     1/208 (0.48%)  
HYPOGLYCEMIAHYPOGLYCEMIA * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
HYPOPROTEINEMIA * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
KETOSIS * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
WEIGHT LOSS * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     1/208 (0.48%)  
Musculoskeletal and connective tissue disorders        
PATHOLOGICAL FRACTURE * 1 [11]      
# participants affected / at risk     0/200 (0.00%)     2/208 (0.96%)     1/208 (0.48%)  
BONE PAIN * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     1/208 (0.48%)  
MYALGIA * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
SPINAL FRACTURE * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
ARTHRALGIA * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
BONE DISORDER * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
OSTEOPOROSIS FRACTURE * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
Nervous system disorders        
CONFUSION * 1 [12]      
# participants affected / at risk     3/200 (1.50%)     3/208 (1.44%)     0/208 (0.00%)  
DIZZINESS * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     1/208 (0.48%)  
HYPOTONIA * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
PARESIS * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     1/208 (0.48%)  
SPINAL CORD COMPRESSION * 1      
# participants affected / at risk     1/200 (0.50%)     1/208 (0.48%)     0/208 (0.00%)  
AGITATION * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
AMNESIA * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
APHASIA * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
CNS DEPRESSION * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
CNS NEOPLASIA * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
COMA * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
CONVULSION * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     1/208 (0.48%)  
DELIRIUM * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
DEPRESSION * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
DYSTONIA * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
EXTRAPYRAMIDAL SYNDROME * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
GRAND MAL CONVULSION * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
HYPESTHESIA * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
INSOMNIA * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
MENTAL STATUS CHANGES * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
NEUROPATHY * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
PARALYSIS * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
PARKINSON'S DISEASE * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
PSYCHOSIS * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
SOMNOLENCE * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     1/208 (0.48%)  
SUICIDAL IDEATION * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
Renal and urinary disorders        
ACUTE KIDNEY FAILURE * 1 [13]      
# participants affected / at risk     6/200 (3.00%)     3/208 (1.44%)     4/208 (1.92%)  
GLOMERULITIS * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
KIDNEY FAILURE * 1      
# participants affected / at risk     1/200 (0.50%)     1/208 (0.48%)     3/208 (1.44%)  
UREMIA * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
URINARY TRACT INFECTION * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
HEMATURIA * 1      
# participants affected / at risk     3/200 (1.50%)     0/208 (0.00%)     0/208 (0.00%)  
KIDNEY FUNCTION ABNORMAL * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     3/208 (1.44%)  
OLIGURIA * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
URINARY INCONTINENCE * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     2/208 (0.96%)  
URINARY RETENTION * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
URINARY TRACT DISORDER * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
Respiratory, thoracic and mediastinal disorders        
PNEUMONIA * 1 [14]      
# participants affected / at risk     3/200 (1.50%)     10/208 (4.81%)     11/208 (5.29%)  
PLEURAL EFFUSION * 1      
# participants affected / at risk     4/200 (2.00%)     6/208 (2.88%)     4/208 (1.92%)  
DYSPNEA * 1      
# participants affected / at risk     9/200 (4.50%)     2/208 (0.96%)     15/208 (7.21%)  
PNEUMONITIS * 1      
# participants affected / at risk     0/200 (0.00%)     2/208 (0.96%)     0/208 (0.00%)  
RESPIRATORY FAILURE * 1      
# participants affected / at risk     3/200 (1.50%)     2/208 (0.96%)     3/208 (1.44%)  
ASTHMA * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     1/208 (0.48%)  
BRONCHITIS * 1      
# participants affected / at risk     1/200 (0.50%)     1/208 (0.48%)     2/208 (0.96%)  
CARCINOMA OF LUNG * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
HEMOTHORAX * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
PHARYNGITIS * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     1/208 (0.48%)  
PNEUMOTHORAX * 1      
# participants affected / at risk     0/200 (0.00%)     1/208 (0.48%)     0/208 (0.00%)  
ASPIRATION * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
BRONCHIOLITIS * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
COUGH INCREASED * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
EPISTAXIS * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
HEMOPTYSIS * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
HYPOXIA * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
LUNG EDEMA * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
LUNG FIBROSIS * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     0/208 (0.00%)  
LUNG INFILTRATION NOS * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
RESPIRATORY DISORDER * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
RESPIRATORY DISTRESS SYNDROME * 1      
# participants affected / at risk     1/200 (0.50%)     0/208 (0.00%)     1/208 (0.48%)  
Skin and subcutaneous tissue disorders        
SKIN CARCINOMA * 1 [15]      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     2/208 (0.96%)  
SKIN ULCER * 1      
# participants affected / at risk     0/200 (0.00%)     0/208 (0.00%)     1/208 (0.48%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, COSTART
[3] Hemic and Lymphatic system
[4] Cardiovascular system
[5] Endocrine system
[6] Special senses
[7] Digestive System
[8] Body as a whole
[9] Adverse event associated with miscellaneous factors
[10] Metabolic and Nutritional
[11] Musculoskeletal system
[12] Nervous system
[13] Urogenital system
[14] Respiratory system
[15] Skin and Appendages




  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Efficacy data was not collected or analyzed after the primary analysis was completed.


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