Trial Outcomes & Findings for Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy (NCT NCT02927249)

NCT ID: NCT02927249

Last Updated: 2023-04-05

Results Overview

Invasive disease-free survival (iDFS), is defined as time from randomization to the first occurrence of any one of the following events for invasive disease: Distant recurrence, locoregional recurrence, ipsilateral or contralateral breast cancer, second primary (non-breast) invasive cancer or death from any cause. Censoring will occur on the date the patient was last known to be alive and free from all invasive breast cancer and second invasive primaries.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 3021 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2023-04-05

Participant Flow

Participant milestones

Measure	Arm I (Aspirin) Patients receive aspirin PO QD for five years in the absence of disease progression or unacceptable toxicity.	Arm II (Placebo) Patients receive placebo PO QD for five years in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	1511	1510
Overall Study COMPLETED	1511	1510
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy

Baseline characteristics by cohort

Measure	Arm I (Aspirin) n=1511 Participants Patients receive aspirin PO QD for five years in the absence of disease progression or unacceptable toxicity.	Arm II (Placebo) n=1510 Participants Patients receive placebo PO QD for five years in the absence of disease progression or unacceptable toxicity.	Total n=3021 Participants Total of all reporting groups
Age, Continuous	53 years n=5 Participants	52 years n=7 Participants	53 years n=5 Participants
Sex: Female, Male Female	1502 Participants n=5 Participants	1503 Participants n=7 Participants	3005 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	112 Participants n=5 Participants	113 Participants n=7 Participants	225 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1368 Participants n=5 Participants	1351 Participants n=7 Participants	2719 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	31 Participants n=5 Participants	46 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	8 Participants n=5 Participants	17 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) Asian	66 Participants n=5 Participants	55 Participants n=7 Participants	121 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Black or African American	140 Participants n=5 Participants	139 Participants n=7 Participants	279 Participants n=5 Participants
Race (NIH/OMB) White	1240 Participants n=5 Participants	1231 Participants n=7 Participants	2471 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	51 Participants n=5 Participants	61 Participants n=7 Participants	112 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Invasive disease-free survival (iDFS), is defined as time from randomization to the first occurrence of any one of the following events for invasive disease: Distant recurrence, locoregional recurrence, ipsilateral or contralateral breast cancer, second primary (non-breast) invasive cancer or death from any cause. Censoring will occur on the date the patient was last known to be alive and free from all invasive breast cancer and second invasive primaries.

Outcome measures

Measure	Arm I (Aspirin) n=1511 Participants Patients receive aspirin PO QD for five years in the absence of disease progression or unacceptable toxicity.	Arm II (Placebo) n=1510 Participants Patients receive placebo PO QD for five years in the absence of disease progression or unacceptable toxicity.
Median Invasive Disease-free Survival (iDFS)	NA Months Not reached due to lack of events	NA Months Not reached due to lack of events

SECONDARY outcome

Timeframe: 5 years

Overall survival (OS) is defined as the time from randomization to death from any cause; surviving patients will be censored at the date last known to be alive.

Outcome measures

Measure	Arm I (Aspirin) n=1511 Participants Patients receive aspirin PO QD for five years in the absence of disease progression or unacceptable toxicity.	Arm II (Placebo) n=1510 Participants Patients receive placebo PO QD for five years in the absence of disease progression or unacceptable toxicity.
Median Overall Survival (OS)	NA Months Not reached due to lack of events	NA Months Not reached due to lack of events

SECONDARY outcome

Timeframe: 5 years

DDFS is defined as the time from randomization to the first occurrence of any one of the following events for invasive disease: Distant recurrence, second primary (non-breast) invasive cancer or death from any cause; censoring will occur at the date the patient was last known to be alive and free from distant invasive breast cancer and second invasive primaries.

Outcome measures

Measure	Arm I (Aspirin) n=1511 Participants Patients receive aspirin PO QD for five years in the absence of disease progression or unacceptable toxicity.	Arm II (Placebo) n=1510 Participants Patients receive placebo PO QD for five years in the absence of disease progression or unacceptable toxicity.
Median Distant Disease Free Survival (DDFS)	NA Months Not reached due to lack of events	NA Months Not reached due to lack of events

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Aspirin)

Serious events: 99 serious events

Other events: 621 other events

Deaths: 48 deaths

Arm II (Placebo)

Serious events: 91 serious events

Other events: 726 other events

Deaths: 43 deaths

Serious adverse events

Measure	Arm I (Aspirin) n=1393 participants at risk Patients receive aspirin PO QD for five years in the absence of disease progression or unacceptable toxicity.	Arm II (Placebo) n=1415 participants at risk Patients receive placebo PO QD for five years in the absence of disease progression or unacceptable toxicity.
Musculoskeletal and connective tissue disorders Arthralgia	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Arthritis	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Back pain	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Inj, pois and proced complic - Oth spec	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Intraoperative breast injury	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Intraoperative neurological injury	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Spinal fracture	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Alanine aminotransferase increased	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Aspartate aminotransferase increased	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Blood bilirubin increased	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Investigations - Other, specify	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Weight gain	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Anorexia	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Hyperkalemia	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Hypoalbuminemia	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Hypokalemia	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Hyponatremia	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Blood and lymphatic system disorders Anemia	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Blood and lymphatic system disorders Febrile neutropenia	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Atrial fibrillation	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Atrial flutter	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Cardiac arrest	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Chest pain - cardiac	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Heart failure	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Myocardial infarction	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Pericarditis	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Supraventricular tachycardia	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Ear and labyrinth disorders Vertigo	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Endocrine disorders Adrenal insufficiency	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Eye disorders Blurred vision	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Eye disorders Eye disorders - Other, specify	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Eye disorders Photophobia	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Abdominal pain	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Ascites	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Colitis	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Dental caries	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Diarrhea	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Dyspepsia	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.42% 6/1415 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Gastritis	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Gastrointestinal disorders - Oth spec	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Nausea	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.28% 4/1415 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Pancreatitis	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Rectal hemorrhage	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Vomiting	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Death NOS	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Fatigue	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Flu like symptoms	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Gen disord and admin site conds-Oth spec	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Non-cardiac chest pain	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Pain	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Sudden death NOS	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Hepatobiliary disorders Cholecystitis	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Hepatobiliary disorders Gallbladder perforation	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Hepatobiliary disorders Hepatic failure	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Appendicitis	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Breast infection	0.14% 2/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.28% 4/1415 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Gallbladder infection	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Infections and infestations - Oth spec	0.50% 7/1393 • Number of events 7 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Lung infection	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Sepsis	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Skin infection	0.22% 3/1393 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.35% 5/1415 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Upper respiratory infection	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Urinary tract infection	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Wound infection	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Ankle fracture	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Bruising	0.43% 6/1393 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.42% 6/1415 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Fall	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Fracture	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal, conn tissue - Oth spec	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Neck pain	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Pain in extremity	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, mal, uncpec - Oth spec	0.29% 4/1393 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.35% 5/1415 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Dizziness	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Dysarthria	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Facial nerve disorder	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Headache	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Intracranial hemorrhage	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Ischemia cerebrovascular	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Nervous system disorders - Oth spec	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Paresthesia	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Seizure	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Stroke	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Syncope	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Transient ischemic attacks	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Tremor	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Vasovagal reaction	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Pregnancy, puerperium and perinatal conditions Pregn, puerperium, perntl cond -Oth spec	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Psychiatric disorders Depression	0.29% 4/1393 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Psychiatric disorders Insomnia	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Psychiatric disorders Suicidal ideation	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Psychiatric disorders Suicide attempt	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Renal and urinary disorders Acute kidney injury	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Renal and urinary disorders Renal and urinary disorders - Oth spec	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Renal and urinary disorders Urinary incontinence	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Reproductive system and breast disorders Reproductive system and breast -Oth spec	0.07% 1/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Cough	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.29% 4/1393 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Resp, thoracic, mediastinal - Oth spec	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Surgical and medical procedures Surgical and medical proced - Oth spec	0.36% 5/1393 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.35% 5/1415 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Vascular disorders Hematoma	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Vascular disorders Hot flashes	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Vascular disorders Hypertension	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Vascular disorders Hypotension	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Vascular disorders Superior vena cava syndrome	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Vascular disorders Thromboembolic event	0.36% 5/1393 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.42% 6/1415 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Vascular disorders Vascular disorders - Other, specify	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.

Other adverse events

Measure	Arm I (Aspirin) n=1393 participants at risk Patients receive aspirin PO QD for five years in the absence of disease progression or unacceptable toxicity.	Arm II (Placebo) n=1415 participants at risk Patients receive placebo PO QD for five years in the absence of disease progression or unacceptable toxicity.
Reproductive system and breast disorders Dyspareunia	0.22% 3/1393 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Reproductive system and breast disorders Irregular menstruation	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Reproductive system and breast disorders Lactation disorder	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Reproductive system and breast disorders Menorrhagia	0.36% 5/1393 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Reproductive system and breast disorders Pelvic pain	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Reproductive system and breast disorders Reproductive system and breast -Oth spec	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.42% 6/1415 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Reproductive system and breast disorders Uterine hemorrhage	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Reproductive system and breast disorders Vaginal dryness	0.79% 11/1393 • Number of events 21 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.1% 15/1415 • Number of events 34 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Reproductive system and breast disorders Vaginal hemorrhage	1.0% 14/1393 • Number of events 15 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.71% 10/1415 • Number of events 13 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Reproductive system and breast disorders Vaginal pain	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.43% 6/1393 • Number of events 9 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Cough	1.7% 23/1393 • Number of events 31 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.5% 21/1415 • Number of events 29 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.79% 11/1393 • Number of events 13 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.5% 21/1415 • Number of events 25 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.9% 40/1393 • Number of events 68 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	4.0% 57/1415 • Number of events 93 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Skin and subcutaneous tissue disorders Nail discoloration	0.07% 1/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Skin and subcutaneous tissue disorders Pain of skin	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Skin and subcutaneous tissue disorders Pruritus	0.14% 2/1393 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.42% 6/1415 • Number of events 7 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Skin and subcutaneous tissue disorders Rash acneiform	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.35% 5/1415 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.72% 10/1393 • Number of events 14 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.71% 10/1415 • Number of events 14 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Skin and subcutaneous tissue disorders Skin and subcut tissue disord - Oth spec	0.93% 13/1393 • Number of events 13 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.2% 17/1415 • Number of events 20 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.14% 2/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.28% 4/1415 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Skin and subcutaneous tissue disorders Skin induration	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Skin and subcutaneous tissue disorders Skin ulceration	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Social circumstances Social circumstances - Other, specify	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Surgical and medical procedures Surgical and medical proced - Oth spec	0.50% 7/1393 • Number of events 7 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.78% 11/1415 • Number of events 12 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Vascular disorders Hematoma	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Vascular disorders Hot flashes	4.7% 66/1393 • Number of events 110 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	5.2% 74/1415 • Number of events 136 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Vascular disorders Hypertension	3.1% 43/1393 • Number of events 78 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	3.5% 50/1415 • Number of events 72 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Vascular disorders Hypotension	0.29% 4/1393 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Vascular disorders Lymphedema	1.0% 14/1393 • Number of events 22 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.3% 19/1415 • Number of events 30 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Vascular disorders Superficial thrombophlebitis	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Vascular disorders Thromboembolic event	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Vascular disorders Vascular disorders - Other, specify	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.36% 5/1393 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Productive cough	0.29% 4/1393 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Resp, thoracic, mediastinal - Oth spec	0.50% 7/1393 • Number of events 7 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.49% 7/1415 • Number of events 8 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Sleep apnea	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Sore throat	0.29% 4/1393 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Respiratory, thoracic and mediastinal disorders Wheezing	0.22% 3/1393 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Skin and subcutaneous tissue disorders Alopecia	0.50% 7/1393 • Number of events 15 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.57% 8/1415 • Number of events 9 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Skin and subcutaneous tissue disorders Dry skin	0.07% 1/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Blood and lymphatic system disorders Anemia	0.93% 13/1393 • Number of events 16 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.64% 9/1415 • Number of events 11 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Blood and lymphatic system disorders Blood and lymph sys disorders - Oth Spec	0.29% 4/1393 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.42% 6/1415 • Number of events 8 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Atrial fibrillation	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Cardiac disorders - Other, specify	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.28% 4/1415 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Chest pain - cardiac	0.07% 1/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Heart failure	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Palpitations	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.28% 4/1415 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Sinus bradycardia	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Sinus tachycardia	0.29% 4/1393 • Number of events 7 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Cardiac disorders Supraventricular tachycardia	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Ear and labyrinth disorders Ear and labyrinth disorders - Oth spec	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Ear and labyrinth disorders Ear pain	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Ear and labyrinth disorders Hearing impaired	0.14% 2/1393 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Ear and labyrinth disorders Tinnitus	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.42% 6/1415 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Ear and labyrinth disorders Vertigo	0.22% 3/1393 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Endocrine disorders Endocrine disorders - Other, specify	0.14% 2/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Endocrine disorders Hyperthyroidism	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Endocrine disorders Hypoparathyroidism	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Endocrine disorders Hypothyroidism	0.07% 1/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.35% 5/1415 • Number of events 7 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Eye disorders Blurred vision	0.43% 6/1393 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.35% 5/1415 • Number of events 8 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Eye disorders Cataract	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Eye disorders Dry eye	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Eye disorders Eye disorders - Other, specify	0.50% 7/1393 • Number of events 7 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.35% 5/1415 • Number of events 9 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Eye disorders Eye pain	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Eye disorders Photophobia	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Eye disorders Retinal detachment	0.07% 1/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Eye disorders Vitreous hemorrhage	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Eye disorders Watering eyes	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Abdominal pain	1.3% 18/1393 • Number of events 27 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.6% 23/1415 • Number of events 29 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Anal hemorrhage	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Bloating	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.35% 5/1415 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Colitis	0.29% 4/1393 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Constipation	1.3% 18/1393 • Number of events 27 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.6% 22/1415 • Number of events 27 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Dental caries	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Diarrhea	1.5% 21/1393 • Number of events 23 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.3% 19/1415 • Number of events 25 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Dry mouth	0.29% 4/1393 • Number of events 9 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Dyspepsia	11.9% 166/1393 • Number of events 337 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	11.9% 168/1415 • Number of events 316 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Dysphagia	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.35% 5/1415 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Esophagitis	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Flatulence	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Gastritis	2.4% 34/1393 • Number of events 45 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	2.6% 37/1415 • Number of events 56 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Gastroesophageal reflux disease	1.2% 17/1393 • Number of events 34 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.6% 22/1415 • Number of events 43 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Gastrointestinal disorders - Oth spec	0.86% 12/1393 • Number of events 14 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.99% 14/1415 • Number of events 16 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Gastrointestinal pain	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.35% 5/1415 • Number of events 7 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Hemorrhoids	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.35% 5/1415 • Number of events 13 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	1.1% 15/1393 • Number of events 18 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.6% 22/1415 • Number of events 32 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Mucositis oral	0.36% 5/1393 • Number of events 7 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.28% 4/1415 • Number of events 9 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Nausea	1.8% 25/1393 • Number of events 36 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	2.4% 34/1415 • Number of events 41 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Oral dysesthesia	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Oral hemorrhage	0.22% 3/1393 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Oral pain	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Periodontal disease	0.14% 2/1393 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Rectal hemorrhage	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Stomach pain	0.65% 9/1393 • Number of events 11 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Gastrointestinal disorders Vomiting	0.36% 5/1393 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.49% 7/1415 • Number of events 7 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Chills	0.29% 4/1393 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Edema face	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Edema limbs	1.1% 16/1393 • Number of events 22 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.2% 17/1415 • Number of events 25 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Fatigue	4.5% 62/1393 • Number of events 87 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	4.2% 59/1415 • Number of events 93 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Fever	0.36% 5/1393 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.35% 5/1415 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Flu like symptoms	0.29% 4/1393 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Gait disturbance	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Gen disord and admin site conds-Oth spec	1.7% 23/1393 • Number of events 34 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.6% 23/1415 • Number of events 36 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Localized edema	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Non-cardiac chest pain	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
General disorders Pain	1.9% 26/1393 • Number of events 32 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	2.9% 41/1415 • Number of events 61 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Hepatobiliary disorders Cholecystitis	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Immune system disorders Allergic reaction	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Immune system disorders Immune system disorders - Other, specify	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Appendicitis	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Breast infection	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Bronchial infection	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Conjunctivitis	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Conjunctivitis infective	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Device related infection	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Eye infection	0.07% 1/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Infections and infestations - Oth spec	0.65% 9/1393 • Number of events 10 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.85% 12/1415 • Number of events 14 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Kidney infection	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Lung infection	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Mucosal infection	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Nail infection	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Otitis media	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Papulopustular rash	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Periorbital infection	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Pharyngitis	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Rash pustular	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Sinusitis	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Skin infection	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.28% 4/1415 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Tooth infection	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Upper respiratory infection	0.36% 5/1393 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.28% 4/1415 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Urinary tract infection	0.50% 7/1393 • Number of events 10 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.64% 9/1415 • Number of events 9 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Vaginal infection	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Infections and infestations Wound infection	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Ankle fracture	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Bruising	12.8% 179/1393 • Number of events 373 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	26.6% 376/1415 • Number of events 841 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Dermatitis radiation	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Fall	0.22% 3/1393 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Fracture	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Hip fracture	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Inj, pois and proced complic - Oth spec	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Seroma	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Wound complication	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Wound dehiscence	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Injury, poisoning and procedural complications Wrist fracture	0.36% 5/1393 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Activated partial throm time prolonged	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Alanine aminotransferase increased	0.29% 4/1393 • Number of events 12 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.64% 9/1415 • Number of events 10 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Alkaline phosphatase increased	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.49% 7/1415 • Number of events 9 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Aspartate aminotransferase increased	0.57% 8/1393 • Number of events 12 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.64% 9/1415 • Number of events 12 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Blood bilirubin increased	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Cholesterol high	0.36% 5/1393 • Number of events 8 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.49% 7/1415 • Number of events 11 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Creatinine increased	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations ECG QT corrected interval prolonged	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Ejection fraction decreased	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations GGT increased	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Hemoglobin increased	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Investigations - Other, specify	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.28% 4/1415 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Lymphocyte count decreased	0.43% 6/1393 • Number of events 15 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.42% 6/1415 • Number of events 10 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Neutrophil count decreased	1.1% 15/1393 • Number of events 26 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.85% 12/1415 • Number of events 19 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Platelet count decreased	0.36% 5/1393 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.42% 6/1415 • Number of events 9 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Weight gain	0.57% 8/1393 • Number of events 12 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.5% 21/1415 • Number of events 43 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations Weight loss	0.36% 5/1393 • Number of events 9 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.28% 4/1415 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Investigations White blood cell decreased	0.79% 11/1393 • Number of events 23 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.92% 13/1415 • Number of events 21 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Acidosis	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Anorexia	0.36% 5/1393 • Number of events 7 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.42% 6/1415 • Number of events 7 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Dehydration	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Glucose intolerance	0.07% 1/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Hypercalcemia	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Hyperglycemia	1.1% 15/1393 • Number of events 22 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.1% 16/1415 • Number of events 28 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Hypertriglyceridemia	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Hypoalbuminemia	0.29% 4/1393 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Hypocalcemia	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Hypokalemia	0.36% 5/1393 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.57% 8/1415 • Number of events 9 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Hyponatremia	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Metabolism, nutrition disord - Oth spec	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Metabolism and nutrition disorders Obesity	0.72% 10/1393 • Number of events 19 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.28% 4/1415 • Number of events 14 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Arthralgia	3.9% 55/1393 • Number of events 104 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	4.1% 58/1415 • Number of events 107 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Arthritis	0.43% 6/1393 • Number of events 10 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.64% 9/1415 • Number of events 13 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Back pain	1.1% 15/1393 • Number of events 17 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.3% 19/1415 • Number of events 24 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Bone pain	0.29% 4/1393 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.92% 13/1415 • Number of events 18 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Chest wall pain	0.57% 8/1393 • Number of events 14 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.49% 7/1415 • Number of events 16 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Flank pain	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Joint range of motion decr cerv spine	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.07% 1/1393 • Number of events 7 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal, conn tissue - Oth spec	1.1% 16/1393 • Number of events 24 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.9% 27/1415 • Number of events 38 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Myalgia	1.3% 18/1393 • Number of events 36 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.4% 20/1415 • Number of events 40 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Myositis	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Neck pain	0.29% 4/1393 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.49% 7/1415 • Number of events 18 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Osteoporosis	0.36% 5/1393 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.49% 7/1415 • Number of events 11 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Pain in extremity	2.0% 28/1393 • Number of events 47 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	2.0% 28/1415 • Number of events 36 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Musculoskeletal and connective tissue disorders Superficial soft tissue fibrosis	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, mal, uncpec - Oth spec	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.42% 6/1415 • Number of events 9 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Amnesia	0.07% 1/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Ataxia	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Cognitive disturbance	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Concentration impairment	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Dizziness	0.79% 11/1393 • Number of events 12 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.85% 12/1415 • Number of events 17 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Dysgeusia	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Facial muscle weakness	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Headache	3.0% 42/1393 • Number of events 60 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	2.6% 37/1415 • Number of events 56 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Intracranial hemorrhage	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Memory impairment	0.22% 3/1393 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.64% 9/1415 • Number of events 11 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Muscle weakness left-sided	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Nervous system disorders - Oth spec	0.14% 2/1393 • Number of events 8 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.35% 5/1415 • Number of events 7 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Neuralgia	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Paresthesia	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.49% 7/1415 • Number of events 8 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.35% 5/1415 • Number of events 6 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Peripheral sensory neuropathy	2.5% 35/1393 • Number of events 55 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	2.9% 41/1415 • Number of events 70 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Presyncope	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Seizure	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Somnolence	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Syncope	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Transient ischemic attacks	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Tremor	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Trigeminal nerve disorder	0.14% 2/1393 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Nervous system disorders Vasovagal reaction	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Pregnancy, puerperium and perinatal conditions Pregn, puerperium, perntl cond -Oth spec	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Psychiatric disorders Agitation	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.28% 4/1415 • Number of events 5 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Psychiatric disorders Anxiety	1.4% 19/1393 • Number of events 29 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.3% 18/1415 • Number of events 25 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Psychiatric disorders Confusion	0.22% 3/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Psychiatric disorders Depression	0.72% 10/1393 • Number of events 10 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.1% 15/1415 • Number of events 25 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Psychiatric disorders Hallucinations	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Psychiatric disorders Insomnia	1.3% 18/1393 • Number of events 34 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.9% 27/1415 • Number of events 44 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Psychiatric disorders Irritability	0.07% 1/1393 • Number of events 3 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Psychiatric disorders Libido decreased	0.14% 2/1393 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.35% 5/1415 • Number of events 9 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Psychiatric disorders Libido increased	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Psychiatric disorders Psychiatric disorders - Other, specify	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Renal and urinary disorders Acute kidney injury	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Renal and urinary disorders Cystitis noninfective	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Renal and urinary disorders Hematuria	1.8% 25/1393 • Number of events 32 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.5% 21/1415 • Number of events 27 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Renal and urinary disorders Proteinuria	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Renal and urinary disorders Renal and urinary disorders - Oth spec	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.00% 0/1415 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Renal and urinary disorders Renal calculi	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Renal and urinary disorders Renal colic	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Renal and urinary disorders Urinary frequency	0.07% 1/1393 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Renal and urinary disorders Urinary incontinence	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.21% 3/1415 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.07% 1/1415 • Number of events 1 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Renal and urinary disorders Urinary tract pain	0.14% 2/1393 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 2 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Renal and urinary disorders Urinary urgency	0.00% 0/1393 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	0.14% 2/1415 • Number of events 4 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.
Reproductive system and breast disorders Breast pain	0.65% 9/1393 • Number of events 17 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.	1.2% 17/1415 • Number of events 27 • 5 years Only treated patients were evaluated for adverse events, all registered patients were evaluated for mortality.

Additional Information

Wendy Chen

Dana Farber Cancer Institute

Phone: 617-632-3800

Email: Wendy_chen@dfci.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place