Trial Outcomes & Findings for Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection (NCT NCT00388674)

NCT ID: NCT00388674

Last Updated: 2018-07-30

Results Overview

The number of participants with Overall Malignant Neoplasm, as adjudicated by Events Adjudication Committee (EAC)

• Recruitment status: COMPLETED
• Target enrollment: 12522 participants
• Primary outcome timeframe: 10 years
• Results posted on: 2018-07-30

Participant Flow

Overall, 12,522 participants were enrolled;12,485 participants were randomized; and12,378 participants received treatment. 100 participants were never treated with the study medication; 3 participants were at participant's request; 2 participants were not reported; 1 participant was administrative reason by sponsor; and 1 was other.

Participant milestones

Measure	Entecavir (ETV) Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily.	Other Anti-HBV Medication (Non-ETV) Standard of care HBV Nucleoside/Nucleotide Monotherapy, specific agent selected at the discretion of the investigator
Initial Treatment STARTED	6216	6162
Initial Treatment COMPLETED	4388	3576
Initial Treatment NOT COMPLETED	1828	2586
End of Study STARTED	6216	6162
End of Study COMPLETED	4482	3993
End of Study NOT COMPLETED	1734	2169

Reasons for withdrawal

Measure	Entecavir (ETV) Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily.	Other Anti-HBV Medication (Non-ETV) Standard of care HBV Nucleoside/Nucleotide Monotherapy, specific agent selected at the discretion of the investigator
Initial Treatment Administrative Reason by Sponsor	241	158
Initial Treatment Adverse Event	22	87
Initial Treatment Death	215	216
Initial Treatment Non-HCC HBV Disease Progression	11	17
Initial Treatment HCC	12	20
Initial Treatment Lost to Follow-up	526	624
Initial Treatment Malignancy (Non-HCC)	7	3
Initial Treatment Never Treated with Study Medication	1	7
Initial Treatment Non-Study related Comorbidities	3	4
Initial Treatment Not Defined	125	172
Initial Treatment Partial or inadequate Treatment	112	472
Initial Treatment Pregnancy	26	16
Initial Treatment Study Drug Toxicity	5	92
Initial Treatment Participant Request	501	673
Initial Treatment No Off-Treatment Status Data	11	13
Initial Treatment Not Reported	10	12
End of Study Administrative Reason By Sponsor	299	253
End of Study Death	239	262
End of Study HBV Disease Progression (Non-HCC)	3	9
End of Study HCC	8	7
End of Study Lost to Follow-up	587	715
End of Study Malignancy (Non-HCC)	1	1
End of Study Non-Study Related Comorbidities	3	4
End of Study Not Defined	135	214
End of Study Participant Withdrew Consent	437	673
End of Study No Off-Treatment Status Data	22	30
End of Study Not Reported	0	1

Baseline Characteristics

Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection

Baseline characteristics by cohort

Measure	Entecavir (ETV) n=6216 Participants Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily.	Other Anti-HBV Medication (Non-ETV) n=6162 Participants Standard of care HBV Nucleoside/Nucleotide Monotherapy, specific agent selected at the discretion of the investigator	Total n=12378 Participants Total of all reporting groups
Age, Continuous	39.8 years STANDARD_DEVIATION 12.11 • n=5 Participants	39.6 years STANDARD_DEVIATION 12.14 • n=7 Participants	39.7 years STANDARD_DEVIATION 12.12 • n=5 Participants
Sex: Female, Male Female	1503 Participants n=5 Participants	1490 Participants n=7 Participants	2993 Participants n=5 Participants
Sex: Female, Male Male	4713 Participants n=5 Participants	4672 Participants n=7 Participants	9385 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	153 Participants n=5 Participants	154 Participants n=7 Participants	307 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6060 Participants n=5 Participants	6008 Participants n=7 Participants	12068 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5221 Participants n=5 Participants	5201 Participants n=7 Participants	10422 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	59 Participants n=5 Participants	68 Participants n=7 Participants	127 Participants n=5 Participants
Race/Ethnicity, Customized White	819 Participants n=5 Participants	780 Participants n=7 Participants	1599 Participants n=5 Participants
Race/Ethnicity, Customized Other	113 Participants n=5 Participants	111 Participants n=7 Participants	224 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 years

Population: All randomized, treated participants

The number of participants with Overall Malignant Neoplasm, as adjudicated by Events Adjudication Committee (EAC)

Outcome measures

Measure	Entecavir (ETV) n=6216 Participants Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily.	Other Anti-HBV Medication (Non-ETV) n=6162 Participants Standard of care HBV Nucleoside/Nucleotide Monotherapy, specific agent selected at the discretion of the investigator
Number of Participants With Adjudicated Overall Malignant Neoplasms	331 Participants Interval 0.8 to 1.084	337 Participants Interval 0.8 to 1.084

PRIMARY outcome

Timeframe: 10 years

Population: All randomized, treated participants

The number of deaths, as adjudicated by Events Adjudication Committee (EAC)

Outcome measures

Measure	Entecavir (ETV) n=6216 Participants Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily.	Other Anti-HBV Medication (Non-ETV) n=6162 Participants Standard of care HBV Nucleoside/Nucleotide Monotherapy, specific agent selected at the discretion of the investigator
Number of Deaths	238 Participants Interval 0.8 to 1.084	264 Participants Interval 0.8 to 1.084

PRIMARY outcome

Timeframe: 10 years

Population: All randomized, treated participants

The number of participants with Liver-related HBV disease progression, as adjudicated by Events Adjudication Committee (EAC)

Outcome measures

Measure	Entecavir (ETV) n=6216 Participants Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily.	Other Anti-HBV Medication (Non-ETV) n=6162 Participants Standard of care HBV Nucleoside/Nucleotide Monotherapy, specific agent selected at the discretion of the investigator
Number of Participants With Liver-related HBV Disease Progression	350 Participants Interval 0.8 to 1.084	375 Participants Interval 0.8 to 1.084

SECONDARY outcome

Timeframe: 10 years

Population: All randomized, treated participants

The number of participants with non-HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC)

Outcome measures

Measure	Entecavir (ETV) n=6216 Participants Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily.	Other Anti-HBV Medication (Non-ETV) n=6162 Participants Standard of care HBV Nucleoside/Nucleotide Monotherapy, specific agent selected at the discretion of the investigator
Number of Participants With Non-HCC Malignant Neoplasm	95 Participants Interval 0.8 to 1.084	81 Participants Interval 0.8 to 1.084

SECONDARY outcome

Timeframe: 10 years

Population: All randomized, treated participants

The number of participants with HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC)

Outcome measures

Measure	Entecavir (ETV) n=6216 Participants Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily.	Other Anti-HBV Medication (Non-ETV) n=6162 Participants Standard of care HBV Nucleoside/Nucleotide Monotherapy, specific agent selected at the discretion of the investigator
Number of Participants With HCC Malignant Neoplasm	240 Participants Interval 0.8 to 1.084	263 Participants Interval 0.8 to 1.084

SECONDARY outcome

Timeframe: 10 years

Population: All randomized, treated participants

The number of participants with Liver-related death, as adjudicated by Events Adjudication Committee (EAC)

Outcome measures

Measure	Entecavir (ETV) n=6216 Participants Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily.	Other Anti-HBV Medication (Non-ETV) n=6162 Participants Standard of care HBV Nucleoside/Nucleotide Monotherapy, specific agent selected at the discretion of the investigator
Number of Participants With Liver-related Death	46 Participants Interval 0.8 to 1.084	48 Participants Interval 0.8 to 1.084

Adverse Events

Entecavir (ETV)

Serious events: 56 serious events

Other events: 0 other events

Deaths: 0 deaths

Other Anti-HBV Medication (Non-ETV)

Serious events: 50 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Entecavir (ETV) n=6216 participants at risk Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily.	Other Anti-HBV Medication (Non-ETV) n=6162 participants at risk Standard of care HBV Nucleoside/Nucleotide Monotherapy, specific agent selected at the discretion of the investigator
Gastrointestinal disorders Ascites	0.05% 3/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Gastrointestinal disorders Enteritis	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Gastrointestinal disorders Pancreatitis	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Gastrointestinal disorders Pancreatitis acute	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.10% 6/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Gastrointestinal disorders Varices oesophageal	0.03% 2/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
General disorders Chest discomfort	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
General disorders Death	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
General disorders Electrocution	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
General disorders Oedema peripheral	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.02% 1/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
General disorders Pelvic mass	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.02% 1/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
General disorders Pyrexia	0.03% 2/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Hepatobiliary disorders Cholelithiasis	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Hepatobiliary disorders Chronic hepatitis	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Hepatobiliary disorders Gallbladder polyp	0.03% 2/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Hepatobiliary disorders Hepatic cirrhosis	0.06% 4/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Hepatobiliary disorders Hepatic fibrosis	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Hepatobiliary disorders Hepatic function abnormal	0.03% 2/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Hepatobiliary disorders Hepatitis	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.02% 1/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Infections and infestations Appendicitis	0.03% 2/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Infections and infestations Chronic hepatitis b	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Infections and infestations Hepatitis b	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.02% 1/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Infections and infestations Hepatitis b reactivation	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Infections and infestations Tuberculous pleurisy	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Injury, poisoning and procedural complications Atypical femur fracture	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.02% 1/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Injury, poisoning and procedural complications Foot fracture	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Injury, poisoning and procedural complications Multiple fractures	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Injury, poisoning and procedural complications Overdose	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Injury, poisoning and procedural complications Road traffic accident	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.02% 1/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Investigations Alanine aminotransferase increased	0.06% 4/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Investigations Blood bilirubin increased	0.03% 2/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Investigations Blood creatine phosphokinase increased	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.05% 3/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Investigations Blood creatinine increased	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.02% 1/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Investigations Weight decreased	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.02% 1/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.06% 4/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.02% 1/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.08% 5/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Musculoskeletal and connective tissue disorders Myalgia	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.02% 1/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.24% 15/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.02% 1/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Musculoskeletal and connective tissue disorders Polymyositis	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.03% 2/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.13% 8/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary cystadenoma lymphomatosum	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Nervous system disorders Cerebral infarction	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Nervous system disorders Coma hepatic	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Nervous system disorders Hepatic encephalopathy	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Nervous system disorders Hypoaesthesia	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.02% 1/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Nervous system disorders Mononeuropathy	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.02% 1/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Nervous system disorders Mononeuropathy multiplex	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.02% 1/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Nervous system disorders Neuropathy peripheral	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.03% 2/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Psychiatric disorders Insomnia	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Renal and urinary disorders Acute kidney injury	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.02% 1/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Renal and urinary disorders Nephropathy	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.05% 3/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Renal and urinary disorders Nephropathy toxic	0.00% 0/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.03% 2/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Renal and urinary disorders Renal impairment	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.02% 1/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.
Renal and urinary disorders Urethral stenosis	0.02% 1/6216 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.	0.00% 0/6162 • 10 years Mandatory reporting of non-serious AEs was not required. Reporting of serious adverse events (SAEs) which are considered unrelated (i.e. not likely or not related) to study drug was also not required.

Other adverse events

Adverse event data not reported

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER