Trial Outcomes & Findings for Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes (NCT NCT01167881)

NCT ID: NCT01167881

Last Updated: 2016-09-02

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1549 participants
• Primary outcome timeframe: Baseline and 104 weeks
• Results posted on: 2016-09-02

Participant Flow

An optional 2-year extension was implemented in this trial through a protocol amendment, which brought the total length of treatment to 4 years. However, some sites did not participate in the 2-year extension, and so considered patients to have completed treatment after 2 years.

Participant milestones

Measure	Empaglifozin 25 mg Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride	Glimepiride Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
Overall Study STARTED	769	780
Overall Study Completed After 2 Years Treatment	95	127
Overall Study Completed After 4 Years Treatment	515	462
Overall Study COMPLETED	610	589
Overall Study NOT COMPLETED	159	191

Reasons for withdrawal

Measure	Empaglifozin 25 mg Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride	Glimepiride Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
Overall Study Adverse Event	47	51
Overall Study Lack of Efficacy	4	7
Overall Study Non compliant with protocol	9	18
Overall Study Lost to Follow-up	19	20
Overall Study Patient refusal to cont., not due to AE	45	40
Overall Study Not treated	4	0
Overall Study Other not defined above	31	55

Baseline Characteristics

Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Empaglifozin 25 mg n=765 Participants Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride	Glimepiride n=780 Participants Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin	Total n=1545 Participants Total of all reporting groups
Age, Continuous	56.2 years STANDARD_DEVIATION 10.3 • n=5 Participants	55.7 years STANDARD_DEVIATION 10.4 • n=7 Participants	55.9 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	333 Participants n=5 Participants	359 Participants n=7 Participants	692 Participants n=5 Participants
Sex: Female, Male Male	432 Participants n=5 Participants	421 Participants n=7 Participants	853 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 104 weeks

Population: FAS (LOCF) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values. .

Outcome measures

Measure	Empaglifozin 25 mg n=765 Participants Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride	Glimepiride n=780 Participants Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.	-0.66 percentage of HbA1c Standard Error 0.03	-0.55 percentage of HbA1c Standard Error 0.03

SECONDARY outcome

Timeframe: baseline and 104 weeks

Population: FAS (LOCF) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.

Outcome measures

Measure	Empaglifozin 25 mg n=765 Participants Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride	Glimepiride n=780 Participants Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
The Change in Body Weight From Baseline After 104 Weeks of Treatment.	-3.11 kilograms Standard Error 0.13	1.33 kilograms Standard Error 0.13

SECONDARY outcome

Timeframe: baseline and 104 weeks

Population: Treated set, all patients treated with at least one dose of randomised study drug.

Outcome measures

Measure	Empaglifozin 25 mg n=765 Participants Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride	Glimepiride n=780 Participants Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.	19 participants	189 participants

SECONDARY outcome

Timeframe: baseline and 104 weeks

Population: FAS (LOCF-H) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values. .

Outcome measures

Measure	Empaglifozin 25 mg n=765 Participants Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride	Glimepiride n=780 Participants Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.	-3.1 mmHg Standard Error 0.5	2.5 mmHg Standard Error 0.5

SECONDARY outcome

Timeframe: baseline and 104 weeks

Population: FAS (LOCF-H) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.

Outcome measures

Measure	Empaglifozin 25 mg n=765 Participants Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride	Glimepiride n=780 Participants Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.	-1.8 mmHg Standard Error 0.3	0.9 mmHg Standard Error 0.3

SECONDARY outcome

Timeframe: baseline and 52 weeks

Population: FAS (LOCF) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.

Outcome measures

Measure	Empaglifozin 25 mg n=765 Participants Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride	Glimepiride n=780 Participants Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
The Change From Baseline in HbA1c After 52 Weeks of Treatment.	-0.73 percentage of HbA1c Standard Error 0.03	-0.66 percentage of HbA1c Standard Error 0.03

SECONDARY outcome

Timeframe: baseline and 52 weeks

Population: FAS (LOCF) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.

Outcome measures

Measure	Empaglifozin 25 mg n=765 Participants Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride	Glimepiride n=780 Participants Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
The Change in Body Weight From Baseline After 52 Weeks of Treatment.	-3.21 kilograms Standard Error 0.12	1.59 kilograms Standard Error 0.11

SECONDARY outcome

Timeframe: baseline and 52 weeks

Population: Treated set, all patients treated with at least one dose of randomised study drug.

Outcome measures

Measure	Empaglifozin 25 mg n=765 Participants Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride	Glimepiride n=780 Participants Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.	12 participants	159 participants

SECONDARY outcome

Timeframe: baseline and 52 weeks

Population: FAS (LOCF-H) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.

Outcome measures

Measure	Empaglifozin 25 mg n=765 Participants Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride	Glimepiride n=780 Participants Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.	-3.6 mmHg Standard Error 0.5	2.2 mmHg Standard Error 0.5

SECONDARY outcome

Timeframe: baseline and 52 weeks

Population: FAS (LOCF-H) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.

Outcome measures

Measure	Empaglifozin 25 mg n=765 Participants Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride	Glimepiride n=780 Participants Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.	-1.9 mmHg Standard Error 0.3	1.0 mmHg Standard Error 0.3

Adverse Events

Empa 25mg

Serious events: 161 serious events

Other events: 580 other events

Deaths: 0 deaths

Glimepiride

Serious events: 153 serious events

Other events: 637 other events

Deaths: 0 deaths

Serious adverse events

Measure	Empa 25mg n=765 participants at risk Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride	Glimepiride n=780 participants at risk Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
Infections and infestations Pelvic abscess	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Infectious mononucleosis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Kidney infection	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Liver abscess	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Lobar pneumonia	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Localised infection	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Lower respiratory tract infection	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Lung infection	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Nasopharyngitis	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Osteomyelitis	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Gastroenteritis	0.52% 4/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Cellulitis	0.39% 3/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Diverticulitis	0.39% 3/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Viral infection	0.39% 3/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Bronchitis	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Erysipelas	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Post procedural infection	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Sepsis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Abscess limb	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Appendicitis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Bacteraemia	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Cystitis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Cystitis escherichia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Dengue fever	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Diarrhoea infectious	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Escherichia bacteraemia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Febrile infection	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Gastroenteritis salmonella	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Hepatitis E	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Peritonitis bacterial	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Pneumonia bacterial	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Pneumonia legionella	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Pyelonephritis	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Pyelonephritis acute	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Salmonellosis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Septic shock	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Sialoadenitis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Tuberculosis gastrointestinal	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Upper respiratory tract infection	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Urosepsis	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.77% 6/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.51% 4/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant peritoneal neoplasm	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma recurrent	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic ocular melanoma	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal neoplasm benign	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paranasal sinus benign neoplasm	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Blood and lymphatic system disorders Anaemia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Blood and lymphatic system disorders Iron deficiency anaemia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Blood and lymphatic system disorders Thrombocytopenia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Immune system disorders Drug hypersensitivity	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.38% 3/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Endocrine disorders Goitre	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Endocrine disorders Pituitary-dependent Cushing's syndrome	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Metabolism and nutrition disorders Obesity	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Metabolism and nutrition disorders Dehydration	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Metabolism and nutrition disorders Electrolyte imbalance	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Metabolism and nutrition disorders Fluid overload	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Metabolism and nutrition disorders Gout	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Metabolism and nutrition disorders Hypokalaemia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Psychiatric disorders Adjustment disorder	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Psychiatric disorders Completed suicide	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Psychiatric disorders Delusional disorder, unspecified type	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Psychiatric disorders Depression	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Psychiatric disorders Mental disorder	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Psychiatric disorders Suicide attempt	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Cerebrovascular accident	1.0% 8/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Carpal tunnel syndrome	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Cerebral haemorrhage	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Dizziness	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Ischaemic stroke	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Transient ischaemic attack	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Brain stem infarction	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Carotid artery stenosis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Cerebral infarction	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Cerebrovascular disorder	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Diabetic coma	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Headache	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Lacunar infarction	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Myasthenia gravis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Myelopathy	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Optic neuritis	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Paraesthesia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Partial seizures	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Radicular pain	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Seizure	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Syncope	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Thalamic infarction	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Trigeminal neuralgia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Eye disorders Retinal detachment	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.38% 3/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Eye disorders Cataract	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Eye disorders Diabetic retinopathy	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Eye disorders Endocrine ophthalmopathy	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Eye disorders Open angle glaucoma	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Eye disorders Retinal neovascularisation	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Eye disorders Vitreous haemorrhage	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Ear and labyrinth disorders Otosclerosis	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Ear and labyrinth disorders Tinnitus	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Ear and labyrinth disorders Vertigo	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Coronary artery disease	0.39% 3/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	1.0% 8/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Acute myocardial infarction	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.90% 7/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Angina unstable	0.52% 4/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.51% 4/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Atrial fibrillation	0.52% 4/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Myocardial infarction	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.38% 3/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Myocardial ischaemia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.38% 3/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Angina pectoris	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Cardiac failure	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Cardiac failure congestive	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Palpitations	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Acute coronary syndrome	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Arrhythmia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Arteriosclerosis coronary artery	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Cardiac disorder	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Cardiac tamponade	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Tachycardia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Ventricle rupture	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Cardiac disorders Ventricular tachycardia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Vascular disorders Deep vein thrombosis	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Vascular disorders Hypertension	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Vascular disorders Hypertensive emergency	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Vascular disorders Orthostatic hypotension	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Vascular disorders Peripheral artery stenosis	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Vascular disorders Peripheral ischaemia	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Vascular disorders Thrombophlebitis	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Vascular disorders Varicose vein	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Respiratory, thoracic and mediastinal disorders Paranasal cyst	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Inguinal hernia	0.52% 4/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.39% 3/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Abdominal pain	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Abdominal pain upper	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Dyspepsia	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Umbilical hernia	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Vomiting	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Abdominal hernia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Anorectal varices	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Anorectal varices haemorrhage	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Colitis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Crohn's disease	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Enterocolitis haemorrhagic	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Gastric ulcer	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Gastritis	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Haemorrhoids	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Hiatus hernia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Intestinal obstruction	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Large intestine polyp	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Pancreatitis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Proctitis haemorrhagic	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Rectal haemorrhage	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Rectal polyp	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Volvulus	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Hepatobiliary disorders Cholelithiasis	0.52% 4/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.64% 5/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Hepatobiliary disorders Cholecystitis acute	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Hepatobiliary disorders Cholangitis	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Hepatobiliary disorders Cholangitis acute	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Hepatobiliary disorders Cholecystitis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Hepatobiliary disorders Cholecystitis chronic	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Hepatobiliary disorders Hepatic cirrhosis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Hepatobiliary disorders Hepatic failure	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Hepatobiliary disorders Hepatitis acute	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Hepatobiliary disorders Liver disorder	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Hepatobiliary disorders Portal hypertension	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Skin and subcutaneous tissue disorders Diabetic foot	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.52% 4/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.51% 4/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Back pain	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Foot deformity	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Arthralgia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Muscle twitching	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Spinal pain	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Synovial cyst	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Synovitis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Renal and urinary disorders Acute kidney injury	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Renal and urinary disorders Nephrolithiasis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Renal and urinary disorders Renal failure	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Renal and urinary disorders Bladder prolapse	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Renal and urinary disorders Calculus ureteric	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Renal and urinary disorders Haematuria	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Renal and urinary disorders Renal cyst	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Renal and urinary disorders Urinary tract obstruction	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.52% 4/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.38% 3/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Reproductive system and breast disorders Menorrhagia	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Reproductive system and breast disorders Balanoposthitis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Reproductive system and breast disorders Prostatism	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Reproductive system and breast disorders Uterine prolapse	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Reproductive system and breast disorders Vaginal prolapse	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Congenital, familial and genetic disorders Phimosis	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
General disorders Chest pain	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.64% 5/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
General disorders Non-cardiac chest pain	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
General disorders Cyst	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
General disorders Hernia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
General disorders Multi-organ failure	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
General disorders Pain	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
General disorders Pyrexia	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
General disorders Sudden death	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Investigations Liver function test abnormal	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Fall	1.0% 8/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Ankle fracture	0.39% 3/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Fibula fracture	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Humerus fracture	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Meniscus injury	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.26% 2/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Tibia fracture	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Traumatic fracture	0.26% 2/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Burns third degree	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Comminuted fracture	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Femur fracture	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Foreign body	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Head injury	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Laceration	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Ligament sprain	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Limb injury	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Overdose	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Post procedural constipation	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Procedural headache	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Radius fracture	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Soft tissue injury	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Surgical and medical procedures Arrhythmia prophylaxis	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Surgical and medical procedures Cholecystectomy	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Surgical and medical procedures Hip arthroplasty	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Surgical and medical procedures Hysterectomy	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Surgical and medical procedures Knee arthroplasty	0.00% 0/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.13% 1/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Surgical and medical procedures Omentectomy	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Surgical and medical procedures Oophorectomy bilateral	0.13% 1/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	0.00% 0/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.

Other adverse events

Measure	Empa 25mg n=765 participants at risk Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride	Glimepiride n=780 participants at risk Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
Infections and infestations Urinary tract infection	17.9% 137/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	15.5% 121/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Nasopharyngitis	11.8% 90/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	13.6% 106/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Upper respiratory tract infection	13.5% 103/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	12.4% 97/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Influenza	9.3% 71/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	9.4% 73/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Bronchitis	4.4% 34/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	8.2% 64/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Gastroenteritis	5.0% 38/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	6.0% 47/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Infections and infestations Pharyngitis	5.5% 42/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	5.6% 44/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Metabolism and nutrition disorders Hypoglycaemia	5.4% 41/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	29.2% 228/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Metabolism and nutrition disorders Hyperglycaemia	19.9% 152/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	29.1% 227/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Metabolism and nutrition disorders Dyslipidaemia	6.7% 51/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	6.2% 48/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Headache	7.7% 59/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	8.7% 68/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Nervous system disorders Dizziness	8.1% 62/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	8.6% 67/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Vascular disorders Hypertension	7.2% 55/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	13.5% 105/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Respiratory, thoracic and mediastinal disorders Cough	6.9% 53/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	7.9% 62/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Gastrointestinal disorders Diarrhoea	8.1% 62/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	8.6% 67/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Back pain	12.2% 93/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	11.5% 90/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Arthralgia	9.2% 70/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	11.0% 86/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 51/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	6.4% 50/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.6% 43/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	5.5% 43/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.
Musculoskeletal and connective tissue disorders Osteoarthritis	3.0% 23/765 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.	5.3% 41/780 • Up to 4 years. All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
• Publication restrictions are in place

Restriction type: OTHER