Trial Outcomes & Findings for HEPSERA Post Marketing Surveillance (NCT NCT01329419)
NCT ID: NCT01329419
Last Updated: 2017-07-05
Results Overview
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record.
Recruitment status
COMPLETED
Target enrollment
4393 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-07-05
Participant Flow
The objective of this post-marketing surveillance (PMS) study was to monitor the safety and efficacy of Hepsera in the real clinical setting after launch.
Participant milestones
| Measure |
Hepsera 10 mg Once a Day
Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
|
|---|---|
|
Overall Study
STARTED
|
4393
|
|
Overall Study
COMPLETED
|
4158
|
|
Overall Study
NOT COMPLETED
|
235
|
Reasons for withdrawal
| Measure |
Hepsera 10 mg Once a Day
Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
|
|---|---|
|
Overall Study
Protocol Violation
|
235
|
Baseline Characteristics
HEPSERA Post Marketing Surveillance
Baseline characteristics by cohort
| Measure |
Hepsera 10 mg Once a Day
n=4158 Participants
Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
|
|---|---|
|
Age, Continuous
|
43.9 Years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
874 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
3280 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Korean
|
4158 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Korean
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record.
Outcome measures
| Measure |
Hepsera 10 mg Once a Day
n=4158 Participants
Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
|
|---|---|
|
Number of Participants With an Adverse Event
|
74 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT Population
A serious adverse event is any untoward medical occurrence that, at any dose: results in death /is life-threatening; requires hospitalization or prolongation of exixting hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is another medically significant event. For a list of all serious adverse events occurring during the course of the study, please see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.
Outcome measures
| Measure |
Hepsera 10 mg Once a Day
n=4158 Participants
Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
|
|---|---|
|
Number of Participants With a Serious Adverse Event
|
32 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT Population
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.
Outcome measures
| Measure |
Hepsera 10 mg Once a Day
n=4158 Participants
Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
|
|---|---|
|
Number of Participants With the Indicated Unexpected Adverse Events
Sputum Increased
|
5 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Hepatic Cirrhosis
|
4 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Hepatic Encephalopathy
|
2 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Hepatic Neoplasm
|
7 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Hypoaesthesia
|
2 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Hemoptysis
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Azotaemia
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Marrow Hyperplasia
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Marrow Depression
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Fracture
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Fasciitis Necrotising
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Skin Reaction Localised
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Myalgia
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Resistance
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Proteinuria
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Edema Peripheral
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Dysuria
|
2 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Pancytopenia
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Ascites
|
3 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Splenomegaly
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Hernia Inguinal
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Esophageal Varices
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Urethral Disorder
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Erythrocytes Abnormal
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Vein Varicose
|
4 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Hemorrhage Rectum
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Gastric Ulcer Hemorrhagic
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Hematemesis
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Pneumonia
|
2 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Pulmonary Carcinoma
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Fatigue
|
3 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Dyspnea
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Jaundice
|
2 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Melaena
|
1 participants
|
Adverse Events
Hepsera 10 mg Once a Day
Serious events: 32 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hepsera 10 mg Once a Day
n=4158 participants at risk
Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
|
|---|---|
|
Hepatobiliary disorders
Hepatic Failure
|
0.22%
9/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.10%
4/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Blood and lymphatic system disorders
Vein Varicose
|
0.07%
3/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Gastric Ulcer Hemorrhagic
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Melaena
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm
|
0.17%
7/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Hematemesis
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Nervous system disorders
Hypoaesthesia
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Hepatobiliary disorders
Hepatic Encephalopathy
|
0.05%
2/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.05%
2/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Hepatobiliary disorders
Jaundice
|
0.05%
2/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Hepatobiliary disorders
Alanine Transaminase/Aspartate Aminotransferase Increased
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
General disorders
Fever
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
General disorders
Ascites
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pulmonary Carcinoma
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Reproductive system and breast disorders
Hernia Inguinal
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.05%
2/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Musculoskeletal and connective tissue disorders
Fasciitis Necrotising
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
Other adverse events
| Measure |
Hepsera 10 mg Once a Day
n=4158 participants at risk
Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.14%
6/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.12%
5/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Gagging
|
0.10%
4/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Flatulence
|
0.10%
4/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
General disorders
Diarrhea
|
0.05%
2/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Esophageal Varices
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Hemorrhage Rectum
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Gastric Ulcer Hemorrhagic
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Hematemesis
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Melaena
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.22%
9/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.10%
4/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Hepatobiliary disorders
Alanine Transaminase/Aspartate Aminotransferase Increased
|
0.05%
2/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Hepatobiliary disorders
Hepatic Encephalopathy
|
0.05%
2/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Hepatobiliary disorders
Hepatitis Chronic Active Aggrava
|
0.05%
2/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Hepatobiliary disorders
Jaundice
|
0.05%
2/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
General disorders
Asthenia
|
0.12%
5/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
General disorders
Ascites
|
0.07%
3/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
General disorders
Fatigue
|
0.07%
3/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
General disorders
Tolerance
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
General disorders
Edema Peripheral
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
General disorders
Fever
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
0.17%
7/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum Increased
|
0.12%
5/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.05%
2/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm
|
0.17%
7/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pulmonary Carcinoma
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Renal and urinary disorders
Dysuria
|
0.05%
2/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Renal and urinary disorders
Azotaemia
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Renal and urinary disorders
Proteinuria
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Renal and urinary disorders
Urethral Disorder
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Renal and urinary disorders
Hematuria
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.07%
3/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Skin and subcutaneous tissue disorders
Skin Reaction Localised
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Blood and lymphatic system disorders
Vein Varicose
|
0.10%
4/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Musculoskeletal and connective tissue disorders
Fasciitis Necrotising
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Nervous system disorders
Hypoaesthesia
|
0.05%
2/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Nervous system disorders
Headache
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Renal and urinary disorders
Hernia Inguinal
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Blood and lymphatic system disorders
Red Blood Cell Abnormality
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Blood and lymphatic system disorders
Marrow Hyperplasia
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Blood and lymphatic system disorders
Marrow Depression
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.02%
1/4158 • February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
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Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER