Trial Outcomes & Findings for Surveillance of Kaletra in Korean Patients (NCT NCT01083173)

NCT ID: NCT01083173

Last Updated: 2016-02-22

Results Overview

Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose.

• Recruitment status: COMPLETED
• Target enrollment: 595 participants
• Primary outcome timeframe: From the start of treatment until 30 days after the last dose, up to 52 weeks
• Results posted on: 2016-02-22

Participant Flow

Participant milestones

Measure	Main Surveillance The safety population included all participants who received at least one dose of Kaletra, and the effectiveness population included all participants who received Kaletra treatment for at least 24 weeks.	Long-term Surveillance The safety population included all participants who received Kaletra for more than 24 weeks, and the effectiveness population included all participants who received Kaletra treatment for at least 48 weeks.
Main Surveillance: Safety Group STARTED	595	0
Main Surveillance: Safety Group COMPLETED	580	0
Main Surveillance: Safety Group NOT COMPLETED	15	0
Main Surveillance: Effectiveness Group STARTED	580	0
Main Surveillance: Effectiveness Group COMPLETED	198	0
Main Surveillance: Effectiveness Group NOT COMPLETED	382	0
Long-term Surveillance: Safety Group STARTED	0	595
Long-term Surveillance: Safety Group COMPLETED	0	479
Long-term Surveillance: Safety Group NOT COMPLETED	0	116
Long-term Surveillance: Effectiveness Gr STARTED	0	479
Long-term Surveillance: Effectiveness Gr COMPLETED	0	102
Long-term Surveillance: Effectiveness Gr NOT COMPLETED	0	377

Reasons for withdrawal

Measure	Main Surveillance The safety population included all participants who received at least one dose of Kaletra, and the effectiveness population included all participants who received Kaletra treatment for at least 24 weeks.	Long-term Surveillance The safety population included all participants who received Kaletra for more than 24 weeks, and the effectiveness population included all participants who received Kaletra treatment for at least 48 weeks.
Main Surveillance: Safety Group Violation of inclusion/exclusion crit.	14	0
Main Surveillance: Safety Group Violation of the use/dosage	1	0
Main Surveillance: Effectiveness Group No follow-up at 24 ±4 wks	201	0
Main Surveillance: Effectiveness Group No viral load data at 24 ±4 wks	168	0
Main Surveillance: Effectiveness Group Administration of Kaletra <24 wks	13	0
Long-term Surveillance: Safety Group Violation of inclusion/exclusion crit.	0	14
Long-term Surveillance: Safety Group Violation of the dosage	0	1
Long-term Surveillance: Safety Group Administration of Kaletra <20 wks	0	101
Long-term Surveillance: Effectiveness Gr No follow-up at 48 ±4 wks	0	195
Long-term Surveillance: Effectiveness Gr No viral load data at 48 ±4 wks	0	136
Long-term Surveillance: Effectiveness Gr Administration of Kaletra <48 wks	0	46

Baseline Characteristics

Surveillance of Kaletra in Korean Patients

Baseline characteristics by cohort

Measure	Overall Study n=580 Participants The main surveillance safety population included all participants who received at least one dose of Kaletra. The long-term surveillance safety population included participants who received Kaletra for more than 24 weeks.
Age, Customized Main Surveillance n= 580	41.3 years STANDARD_DEVIATION 12.5 • n=5 Participants
Age, Customized Long-term Surveillance n=479	41 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex/Gender, Customized Main Surveillance Females	56 participants n=5 Participants
Sex/Gender, Customized Main Surveillance Males	524 participants n=5 Participants
Sex/Gender, Customized Long-Term Surveillance Females	47 participants n=5 Participants
Sex/Gender, Customized Long-Term Surveillance Males	432 participants n=5 Participants

PRIMARY outcome

Timeframe: From the start of treatment until 30 days after the last dose, up to 52 weeks

Population: Participants with available data

Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose.

Outcome measures

Measure	Main Surveillance n=580 Participants All participants who received at least one dose of Kaletra	Long-term Surveillance n=479 Participants Participants who received Kaletra for more than 24 weeks
Number of Participants With Adverse Events	363 participants	285 participants

PRIMARY outcome

Timeframe: Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment

Population: Participants with available data

At 24 and 48 weeks after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment, the investigator documented Kaletra status (on-going, permanently discontinued, lost to follow-up, etc).

Outcome measures

Measure	Main Surveillance n=580 Participants All participants who received at least one dose of Kaletra	Long-term Surveillance n=479 Participants Participants who received Kaletra for more than 24 weeks
Number of Participants Who Interrupted or Discontinued Kaletra Treatment	120 participants	43 participants

PRIMARY outcome

Timeframe: Week 24

Population: Participants with available data

Blood samples were obtained from participants 24 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.

Outcome measures

Measure	Main Surveillance n=198 Participants All participants who received at least one dose of Kaletra	Long-term Surveillance Participants who received Kaletra for more than 24 weeks
Percentage of Participants With Viral Load Below 400 Copies/mL	92.4 percentage of participants	—

PRIMARY outcome

Timeframe: Week 48

Population: Participants with available data

Blood samples were obtained from participants 48 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.

Outcome measures

Measure	Main Surveillance n=102 Participants All participants who received at least one dose of Kaletra	Long-term Surveillance Participants who received Kaletra for more than 24 weeks
Percentage of Participants With Viral Load Below 50 Copies/mL	68.6 percentage of participants	—

SECONDARY outcome

Timeframe: Week 24 & 48

This variable, change from baseline in viral load, was not included in the final protocol. Therefore, these data were not calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to Weeks 24 and 48

Population: Participants with available data

Blood samples were obtained from participants at baseline, 24, and 48 weeks after the start of Kaletra treatment and analyzed for CD4 cell counts. Change in CD4 cell counts in the main surveillance population was calculated by subtracting the value at baseline from the value at 24 weeks. Change in CD4 cell counts in the long-term surveillance population was calculated by subtracting the value at baseline from the value at 48 weeks.

Outcome measures

Measure	Main Surveillance n=181 Participants All participants who received at least one dose of Kaletra	Long-term Surveillance n=93 Participants Participants who received Kaletra for more than 24 weeks
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts	145.47 cells/mm˄3 Standard Deviation 144.28	170.47 cells/mm˄3 Standard Deviation 159.30

SECONDARY outcome

Timeframe: From baseline through weeks 24 and 48

Population: Participants with available data

Blood samples were obtained from participants at initiation of Kaletra treatment and follow up visits through weeks 24 and 48 and analyzed for genotypic viral resistance.

Outcome measures

Measure	Main Surveillance n=198 Participants All participants who received at least one dose of Kaletra	Long-term Surveillance n=102 Participants Participants who received Kaletra for more than 24 weeks
Percentage of Participants With Confirmed Viral Resistance	0.51 percentage of participants	1.96 percentage of participants

SECONDARY outcome

Timeframe: From baseline through weeks 24 and 48

Population: Participants with available data

Blood samples were obtained from participants at initiation of Kaletra treatment and at follow up visits through weeks 24 and 48 and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. Treatment failure was defined as HIV RNA level > 400 copies/mL at week 24 and HIV RNA level > 50 copies/mL at week 48.

Outcome measures

Measure	Main Surveillance n=198 Participants All participants who received at least one dose of Kaletra	Long-term Surveillance n=102 Participants Participants who received Kaletra for more than 24 weeks
Mean Time to Treatment Failure	399.97 days Standard Error 3.45	410.8 days Standard Error 1.03

Adverse Events

Main Surveillance

Serious events: 51 serious events

Other events: 222 other events

Deaths: 0 deaths

Long-term Surveillance

Serious events: 39 serious events

Other events: 169 other events

Deaths: 0 deaths

Serious adverse events

Measure	Main Surveillance n=580 participants at risk All participants who received at least one dose of Kaletra	Long-term Surveillance n=479 participants at risk Participants who received Kaletra for more than 24 weeks
Blood and lymphatic system disorders Anaemia	0.86% 5/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	1.0% 5/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Blood and lymphatic system disorders Neutropenia	0.34% 2/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.42% 2/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Blood and lymphatic system disorders Bone marrow failure	0.52% 3/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.63% 3/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Blood and lymphatic system disorders Pancytopenia	0.34% 2/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.00% 0/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Blood and lymphatic system disorders Lymphadenitis	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Cardiac disorders Acute myocardial infarction	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Eye disorders Retinal detachment	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Eye disorders Retinal haemorrhage	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Gastrointestinal disorders Diarrhoea	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Gastrointestinal disorders Nausea	0.34% 2/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Gastrointestinal disorders Vomiting	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.00% 0/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
General disorders Asthenia	0.34% 2/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.42% 2/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
General disorders Chest discomfort	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.00% 0/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Hepatobiliary disorders Hepatic cirrhosis	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Hepatobiliary disorders Hepatic failure	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Hepatobiliary disorders Liver disorder	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.00% 0/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Immune system disorders Anaphylactic reaction	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Infections and infestations Herpes zoster	0.86% 5/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	1.0% 5/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Infections and infestations Pneumocystis jirovecii pneumonia	1.4% 8/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	1.0% 5/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Infections and infestations Cytomegalovirus chorioretinitis	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Infections and infestations Pneumonia	0.69% 4/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.63% 3/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Infections and infestations Progressive multifocal leukoencephalopathy	0.34% 2/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Infections and infestations Disseminated tuberculosis	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Infections and infestations Pneumonia bacterial	0.34% 2/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.42% 2/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Infections and infestations Arthritis bacterial	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Infections and infestations Gastroenteritis	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Infections and infestations Lobar pneumonia	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Infections and infestations Mycobacterial infection	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.00% 0/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Infections and infestations Pneumonia cytomegaloviral	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.00% 0/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Infections and infestations Sepsis	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Infections and infestations Septic shock	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Infections and infestations Spleen tuberculosis	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Injury, poisoning and procedural complications Radius fracture	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Investigations Blood triglycerides increased	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.00% 0/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Investigations Blood pressure decreased	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.00% 0/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Metabolism and nutrition disorders Decreased appetite	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Metabolism and nutrition disorders Hyponatraemia	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Metabolism and nutrition disorders Dehydration	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Metabolism and nutrition disorders Electrolyte imbalance	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Metabolism and nutrition disorders Hyperkalaemia	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Metabolism and nutrition disorders Malnutrition	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.00% 0/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's sarcoma	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.00% 0/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Nervous system disorders Cerebral infarction	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Nervous system disorders Convulsion	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Nervous system disorders Dizziness	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.00% 0/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Nervous system disorders Encephalopathy	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.00% 0/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Nervous system disorders Syncope	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.00% 0/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Pregnancy, puerperium and perinatal conditions Premature labour	0.34% 2/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.42% 2/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Psychiatric disorders Depression	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Renal and urinary disorders Renal failure acute	0.34% 2/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Renal and urinary disorders Renal failure	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.00% 0/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.00% 0/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Skin and subcutaneous tissue disorders Rash generalised	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Vascular disorders Hypotension	0.17% 1/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	0.21% 1/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.

Other adverse events

Measure	Main Surveillance n=580 participants at risk All participants who received at least one dose of Kaletra	Long-term Surveillance n=479 participants at risk Participants who received Kaletra for more than 24 weeks
Gastrointestinal disorders Diarrhoea	20.5% 119/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	18.4% 88/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Gastrointestinal disorders Nausea	12.1% 70/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	10.2% 49/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
Infections and infestations Nasopharyngitis	5.7% 33/580 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.	6.7% 32/479 • From the start of treatment until 30 days after the last dose, up to 52 weeks Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.

Additional Information

Global Medical Information

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER