Trial Outcomes & Findings for Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma (NCT NCT01076543)

Last Updated: 2019-10-16

Results Overview

Incidence of dose-limiting toxicity (DLT) defined as any grade 3 or 4 adverse events as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

110 participants

Primary outcome timeframe

28 days

Results posted on

2019-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Phase I, All Histologies, Lenalidomide 15 mg Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 20 mg Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 25 mg Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Diffuse Large B-Cell Subtype Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Follicular Subtype Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Lymphoma NOS Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
Overall Study STARTED	8	3	6	39	15	39
Overall Study COMPLETED	6	3	6	39	15	39
Overall Study NOT COMPLETED	2	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I, All Histologies, Lenalidomide 15 mg Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 20 mg Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 25 mg Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Diffuse Large B-Cell Subtype Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Follicular Subtype Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Lymphoma NOS Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
Overall Study Withdrawal by Subject	2	0	0	0	0	0

Baseline Characteristics

Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I, All Histologies, Lenalidomide 15 mg n=8 Participants Patients receive lenalidomide 15 mg PO on days 1-21 and25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 20 mg n=3 Participants Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 25 mg n=6 Participants Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Diffuse Large B-Cell Subtype n=39 Participants Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Follicular Subtype n=15 Participants Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Lymphoma NOS n=39 Participants Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Total n=110 Participants Total of all reporting groups
Age, Continuous	60.9 years n=5 Participants	65.2 years n=7 Participants	65.3 years n=5 Participants	64.1 years n=4 Participants	63.3 years n=21 Participants	47.4 years n=10 Participants	57.9 years n=115 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants	6 Participants n=21 Participants	14 Participants n=10 Participants	36 Participants n=115 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	28 Participants n=4 Participants	9 Participants n=21 Participants	25 Participants n=10 Participants	74 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	3 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=10 Participants	14 Participants n=115 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	33 Participants n=4 Participants	12 Participants n=21 Participants	29 Participants n=10 Participants	88 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	4 Participants n=115 Participants
Region of Enrollment United States	8 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants	39 participants n=4 Participants	15 participants n=21 Participants	39 participants n=10 Participants	110 participants n=115 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Only phase I patients were assessed for dose-limiting toxicity per 3+3 dose-escalation design to determine the maximum tolerated dose (MTD).

Outcome measures

Outcome measures
Measure	Phase I, All Histologies, Lenalidomide 15 mg n=6 Participants Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 20 mg n=3 Participants Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 25 mg n=6 Participants Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Diffuse Large B-Cell Subtype Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Follicular Subtype Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Lymphoma NOS Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
Incidence of Dose-limiting Toxicity (DLT), Phase I Patients Only	1 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: Only phase II patients were assessed for complete response.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions;

Outcome measures

Outcome measures
Measure	Phase I, All Histologies, Lenalidomide 15 mg Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 20 mg Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 25 mg Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Diffuse Large B-Cell Subtype n=39 Participants Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Follicular Subtype n=15 Participants Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Lymphoma NOS n=39 Participants Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
Complete Response (Phase II)	0 Participants	0 Participants	0 Participants	5 Participants	5 Participants	7 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: Only phase II patients were assessed for overall response.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Phase I, All Histologies, Lenalidomide 15 mg Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 20 mg Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 25 mg Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Diffuse Large B-Cell Subtype n=39 Participants Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Follicular Subtype n=15 Participants Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Lymphoma NOS n=39 Participants Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
Overall Response Rate (Phase II)	0 Participants	0 Participants	0 Participants	10 Participants	7 Participants	25 Participants

SECONDARY outcome

Timeframe: Time from study entry until disease progression or death from any cause, assessed up to 5 years

Population: Note: Only phase II patients were followed for progression-free survival.

Kaplan-Meier curves will be generated for PFS stratified by histology; median PFS times will be determined and 90% confidence intervals derived as described in Brookmeyer and Crowley.

Outcome measures

Outcome measures
Measure	Phase I, All Histologies, Lenalidomide 15 mg Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 20 mg Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 25 mg Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Diffuse Large B-Cell Subtype n=39 Participants Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Follicular Subtype n=15 Participants Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Lymphoma NOS n=39 Participants Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
Progression-free Survival (PFS) (Phase II)	—	—	—	7.0 Months Interval 3.5 to 8.0	27.7 Months Interval 6.5 to 35.8	7.0 Months Interval 4.6 to 9.9

SECONDARY outcome

Timeframe: Time from study entry until death from any cause, assessed up to 6 years

Population: Only phase II patients were followed for overall survival. Note:999999 for the upper confidence interval of the median for the follicular subtype means "not estimable."

Kaplan-Meier curves will be generated for OS stratified by histology; median OS times will be determined and 90% confidence intervals derived as described in Brookmeyer and Crowley.

Outcome measures

Outcome measures
Measure	Phase I, All Histologies, Lenalidomide 15 mg Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 20 mg Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 25 mg Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Diffuse Large B-Cell Subtype n=39 Participants Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Follicular Subtype n=15 Participants Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Lymphoma NOS n=39 Participants Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
Overall Survival (OS) (Phase II)	—	—	—	9.1 Months Interval 6.0 to 16.0	35.8 Months Interval 18.8 to The upper confidence limit could not be determined due to the censoring.	25.5 Months Interval 10.8 to 60.6

Adverse Events

Phase I, All Histologies, Lenalidomide 15 mg

Serious events: 2 serious events

Other events: 8 other events

Deaths: 4 deaths

Phase I, All Histologies, Lenalidomide 20 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Phase I, All Histologies, Lenalidomide 25 mg

Serious events: 5 serious events

Other events: 6 other events

Deaths: 4 deaths

Phase II, Diffuse Large B-Cell Subtype

Serious events: 22 serious events

Other events: 39 other events

Deaths: 23 deaths

Phase II, Follicular Subtype

Serious events: 7 serious events

Other events: 13 other events

Deaths: 4 deaths

Phase II, Lymphoma NOS

Serious events: 22 serious events

Other events: 39 other events

Deaths: 18 deaths

Serious adverse events

Serious adverse events
Measure	Phase I, All Histologies, Lenalidomide 15 mg n=8 participants at risk Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 20 mg n=3 participants at risk Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 25 mg n=6 participants at risk Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Diffuse Large B-Cell Subtype n=39 participants at risk Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Follicular Subtype n=15 participants at risk Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Lymphoma NOS n=39 participants at risk Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
Respiratory, thoracic and mediastinal disorders Pneumonitis	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Vomiting	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Diarrhea	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Infection	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	66.7% 2/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Blood and lymphatic system disorders Anemia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Cardiac disorders Chest pain - cardiac	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations Lymphocyte count decreased	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Oral pain	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations Platelet count decreased	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.5% 8/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Cardiac disorders Sinus bradycardia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Vascular disorders Thromboembolic event	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Urinary tract infection	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Vascular disorders Vascular disorders - other	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Psychiatric disorders Agitation	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations Creatinine increased	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Nervous system disorders Dysgeusia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Injury, poisoning and procedural complications Fall	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
General disorders Fever	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Nervous system disorders Headache	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Blood and lymphatic system disorders INR increased	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Psychiatric disorders Mood alteration - depression	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Cardiac disorders Myocardial infarction	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Nausea	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations Neutrophil count decreased	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Sepsis	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Skin and subcutaneous tissue disorders Skin and subcutaneous disorders - other	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Stomatitis/Pharyngitis	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Nervous system disorders Stroke	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Tooth infection	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Upper respiratory infection	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations White blood cell decreased	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Renal and urinary disorders Acute kidney injury	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Eye disorders Blurred vision	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Catheter related infection	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Hepatobiliary disorders Cholecystitis	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Nervous system disorders Lethargy	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Lung infection	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	10.3% 4/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Obstruction gastric	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Anorexia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Cardiac disorders Cardiac arrest	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Colonic perforation	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Colonic ulcer	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
General disorders Death NOS	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Nervous system disorders Dysphasia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
General disorders Fatigue	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Vascular disorders Hypertension	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Vascular disorders Hypotension	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant, and unspecified	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Rectal pain	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Cardiac disorders Sick sinus syndrome	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Sinusitis	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Surgical and medical procedures Surgical and medical procedures - other	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.

Other adverse events

Other adverse events
Measure	Phase I, All Histologies, Lenalidomide 15 mg n=8 participants at risk Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 20 mg n=3 participants at risk Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase I, All Histologies, Lenalidomide 25 mg n=6 participants at risk Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Diffuse Large B-Cell Subtype n=39 participants at risk Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Follicular Subtype n=15 participants at risk Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	Phase II, Lymphoma NOS n=39 participants at risk Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
Gastrointestinal disorders Tooth development disorder	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Renal and urinary disorders Urinary retention	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations Aspartate aminotransferase increased	50.0% 4/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	38.5% 15/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	40.0% 6/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	51.3% 20/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hypoalbuminemia	37.5% 3/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	100.0% 3/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	66.7% 4/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	30.8% 12/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	26.7% 4/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	48.7% 19/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations Lymphocyte count decreased	62.5% 5/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	66.7% 2/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 2/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	71.8% 28/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	66.7% 10/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	79.5% 31/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Abdominal pain	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	23.1% 9/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	17.9% 7/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations Alkaline aminotransferase increase	50.0% 4/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 2/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	30.8% 12/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	46.7% 7/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	53.8% 21/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations Alkaline phosphatase increased	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	23.1% 9/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	40.0% 6/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	43.6% 17/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	12.8% 5/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Blood and lymphatic system disorders Anemia	87.5% 7/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	66.7% 2/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	66.7% 4/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	84.6% 33/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	66.7% 10/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	92.3% 36/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Anorexia	50.0% 4/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	50.0% 3/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	51.3% 20/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	53.3% 8/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	46.2% 18/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Blood and lymphatic system disorders Bleeding	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	17.9% 7/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	23.1% 9/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations Neutrophil count decreased	62.5% 5/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	66.7% 2/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	50.0% 3/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	71.8% 28/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	60.0% 9/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	66.7% 26/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Skin and subcutaneous tissue disorders Pruritis	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	50.0% 3/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	30.8% 12/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	40.0% 6/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	35.9% 14/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations Blood bilirubin increased	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Skin and subcutaneous tissue disorders Nail discoloration	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
General disorders Chills	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	12.8% 5/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	23.1% 9/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations Cholesterol high	50.0% 4/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	28.2% 11/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.0% 3/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	41.0% 16/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Constipation	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 2/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	43.6% 17/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	53.3% 8/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	46.2% 18/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations Creatinine increased	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	25.6% 10/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 5/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	28.2% 11/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Cough	37.5% 3/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	50.0% 3/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	30.8% 12/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	40.0% 6/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	35.9% 14/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Dental caries	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Nausea	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 2/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	30.8% 12/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	26.7% 4/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	30.8% 12/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Diarrhea	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 2/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	35.9% 14/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	26.7% 4/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	35.9% 14/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Nervous system disorders Dizziness	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	50.0% 3/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	15.4% 6/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	26.7% 4/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	15.4% 6/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Eye disorders Dry eye	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Dry mouth	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 2/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	10.3% 4/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	15.4% 6/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Nervous system disorders Dysgeusia	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 2/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	23.1% 9/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	46.7% 7/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	15.4% 6/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	50.0% 3/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	15.4% 6/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	40.0% 6/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	15.4% 6/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
General disorders Edema limbs	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	66.7% 2/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	23.1% 9/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	53.3% 8/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.5% 8/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
General disorders Neck edema	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Enterocolitis	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
General disorders Fatigue	62.5% 5/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	66.7% 4/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	64.1% 25/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	80.0% 12/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	79.5% 31/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
General disorders Fever	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	28.2% 11/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.0% 3/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	43.6% 17/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Nervous system disorders Neuropathy-sensory	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	66.7% 2/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	15.4% 6/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 5/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.5% 8/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Flatulence	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Vascular disorders Flushing	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Renal and urinary disorders Hematuria	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hypercalcemia	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	15.4% 6/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hyperglycemia	50.0% 4/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	100.0% 3/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	50.0% 3/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	74.4% 29/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	60.0% 9/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	84.6% 33/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hypermagnesemia	37.5% 3/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hypernatremia	37.5% 3/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.5% 8/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	12.8% 5/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Vascular disorders Hypertension	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	25.6% 10/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.0% 3/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.5% 8/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hypertriglyceridemia	62.5% 5/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	38.5% 15/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	26.7% 4/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	51.3% 20/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hypocalcemia	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	100.0% 3/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	50.0% 3/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	59.0% 23/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	40.0% 6/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	61.5% 24/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hypokalemia	50.0% 4/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	100.0% 3/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 2/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	59.0% 23/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	46.7% 7/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	76.9% 30/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hypomagnesemia	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	30.8% 12/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	28.2% 11/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Infection	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	15.4% 6/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Psychiatric disorders Insomnia	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 2/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	15.4% 6/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.0% 3/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	17.9% 7/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Localized edema	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	10.3% 4/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	23.1% 9/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Blood and lymphatic system disorders Lymph node pain	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
General disorders Pain	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 2/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	35.9% 14/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	40.0% 6/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.5% 8/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	10.3% 4/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations Platelet count decreased	87.5% 7/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	66.7% 2/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	83.3% 5/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	82.1% 32/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	80.0% 12/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	82.1% 32/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Postnasal drip	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	37.5% 3/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	46.2% 18/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	53.3% 8/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	35.9% 14/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Skin and subcutaneous tissue disorders Rash/dermatitis	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	30.8% 12/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	26.7% 4/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.5% 8/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Sinus disorder	25.0% 2/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Nervous system disorders Sinus pain	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Sinusitis	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	26.7% 4/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - other	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Skin infection	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	12.8% 5/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Skin and subcutaneous tissue disorders Skin ulceration	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Skin and subcutaneous tissue disorders Urticaria	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Vomiting	12.5% 1/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	17.9% 7/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	15.4% 6/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations White blood cell decreased	62.5% 5/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	100.0% 3/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	83.3% 5/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	82.1% 32/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	66.7% 10/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	87.2% 34/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	10.3% 4/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations CD4 lymphocytes decreased	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
General disorders Flu like symptoms	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 2/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	15.4% 6/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 13/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	23.1% 9/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	28.2% 11/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations Lymphocyte count increased	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Reproductive system and breast disorders Vaginal pain	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 1/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Psychiatric disorders Agitation	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Eye disorders Blurred vision	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 2/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	10.3% 4/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	10.3% 4/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.0% 3/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Gum infection	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Endocrine disorders Hypothryoidism	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	33.3% 2/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	17.9% 7/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Nervous system disorders Nervous system disorders - other	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Oral pain	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	17.9% 7/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Nervous system disorders Somnolence	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.5% 8/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.5% 8/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Stomatitis/pharyngitis	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	17.9% 7/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	26.7% 4/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	28.2% 11/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Upper respiratory infection	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	10.3% 4/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.0% 3/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	10.3% 4/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Urinary tract infection	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	10.3% 4/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	16.7% 1/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Immune system disorders Allergic reaction	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Psychiatric disorders Anxiety	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	10.3% 4/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	17.9% 7/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Eye disorders Cataract	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Renal and urinary disorders Chronic kidney disease	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Dyspepsia/heartburn	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
General disorders Edema face	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Esophagitis	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
General disorders Facial pain	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Injury, poisoning and procedural complications Fall	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Nervous system disorders Headache	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	17.9% 7/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	12.8% 5/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	15.4% 6/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	12.8% 5/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Vascular disorders Hypotension	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	12.8% 5/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	17.9% 7/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Blood and lymphatic system disorders INR increased	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Lung infection	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Psychiatric disorders Mood alteration - depression	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	12.8% 5/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Non-cardiac chest pain	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	15.4% 6/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.0% 3/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Papulopustular rash	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	10.3% 4/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Nervous system disorders Paresthesia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Stomach pain	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Vascular disorders Thromboembolic event	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.0% 3/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Nervous system disorders Tremor	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Renal and urinary disorders Acute kidney injury	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	10.3% 4/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Bronchial infection	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Injury, poisoning and procedural complications Bruising	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Catheter related infection	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Dysphagia, esophagitis, odynophagia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.0% 3/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	12.8% 5/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Eye infection	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Eye disorders Floaters	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Gingival pain	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Endocrine disorders Hyperparathyroidism	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Musculoskeletal and connective tissue disorders Joint range of motion decreased lumbar spine	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Malaise	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Nail infection	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Skin and subcutaneous tissue disorders Nail loss	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Nervous system disorders Neuropathy - motor	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Oral dysesthesia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Otitis externa	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Paronychia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Renal and urinary disorders Proteinuria	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Rash pustular	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Skin and subcutaneous tissue disorders Scalp pain	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Immune system disorders Serum sickness	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Cardiac disorders Sick sinus syndrome	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Vascular disorders Superficial thrombophlebitis	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Ear and labyrinth disorders Tinnitus	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Tooth infection	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	13.3% 2/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Toothache	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	20.0% 3/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	7.7% 3/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Renal and urinary disorders Urinary frequency	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	10.3% 4/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Wound infection	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	6.7% 1/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
General disorders Edema trunk	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Vascular disorders Hot flashes	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - other	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Investigations Investigations - other	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Infections and infestations Pharyngitis	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Gastrointestinal disorders Rectal pain	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Cardiac disorders Sinus tachycardia	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/8 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/3 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/6 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	2.6% 1/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	0.00% 0/15 • Mortality collected up to 6 years; all other AEs collected up to 2 years.	5.1% 2/39 • Mortality collected up to 6 years; all other AEs collected up to 2 years.

Additional Information

Dr. Sonali Smith, Professor of Medicine

University of Chicago

Phone: 773-834-2895

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60