Trial Outcomes & Findings for Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors (NCT NCT00838539)

Last Updated: 2018-09-18

Results Overview

A DLT was defined as any dose-limiting Adverse Event related to neratinib + Temsirolimus as Grade 3 or higher nonhematologic toxicity (except neutropenia) or Grade 3 or higher diarrhea lasting \>2 days with optimal antidiarrheal therapy etc.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

63 participants

Primary outcome timeframe

From first dose date to day 28

Results posted on

2018-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	N120 + T15 Neratinib 120 mg + Temsirolimus 15 mg	N120 + T25 Neratinib 120 mg + Temsirolimus 25 mg	N120 + T50 Neratinib 120 mg + Temsirolimus 50 mg	N120 + T75 Neratinib 120 mg + Temsirolimus 75 mg	N160 + T15 Neratinib 160 mg + Temsirolimus 15 mg	N160 + T25 Neratinib 160 mg + Temsirolimus 25 mg	N160 + T50 Neratinib 160 mg + Temsirolimus 50 mg	N160 + T75 Neratinib 160 mg + Temsirolimus 75 mg	N200 + T15 Neratinib 200 mg + Temsirolimus 15 mg	N200 + T25 Neratinib 200 mg + Temsirolimus 25 mg	N200 + T50 Neratinib 200 mg + Temsirolimus 50 mg	N240 + T15 Neratinib 240 mg + Temsirolimus 15 mg
Overall Study STARTED	3	6	5	4	6	4	7	6	5	8	5	4
Overall Study Received Treatment	3	5	5	4	4	4	7	6	5	8	5	4
Overall Study COMPLETED	0	0	0	0	0	0	2	0	0	0	0	0
Overall Study NOT COMPLETED	3	6	5	4	6	4	5	6	5	8	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	N120 + T15 Neratinib 120 mg + Temsirolimus 15 mg	N120 + T25 Neratinib 120 mg + Temsirolimus 25 mg	N120 + T50 Neratinib 120 mg + Temsirolimus 50 mg	N120 + T75 Neratinib 120 mg + Temsirolimus 75 mg	N160 + T15 Neratinib 160 mg + Temsirolimus 15 mg	N160 + T25 Neratinib 160 mg + Temsirolimus 25 mg	N160 + T50 Neratinib 160 mg + Temsirolimus 50 mg	N160 + T75 Neratinib 160 mg + Temsirolimus 75 mg	N200 + T15 Neratinib 200 mg + Temsirolimus 15 mg	N200 + T25 Neratinib 200 mg + Temsirolimus 25 mg	N200 + T50 Neratinib 200 mg + Temsirolimus 50 mg	N240 + T15 Neratinib 240 mg + Temsirolimus 15 mg
Overall Study Disease Progression	2	4	3	2	4	2	3	4	4	5	1	4
Overall Study Adverse Event	1	1	1	1	2	1	0	2	0	1	2	0
Overall Study Withdrawal by Subject	0	1	0	0	0	0	0	0	0	1	2	0
Overall Study Death	0	0	0	0	0	0	1	0	0	0	0	0
Overall Study Physician Decision	0	0	0	0	0	0	0	0	1	0	0	0
Overall Study Clinical Progression	0	0	0	0	0	0	1	0	0	0	0	0
Overall Study Symptomatic Deterioration	0	0	1	1	0	1	0	0	0	1	0	0

Baseline Characteristics

Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	N120 + T15 n=3 Participants Neratinib 120 mg qd + Temsirolimus 15 mg, IV, weekly	N120 + T25 n=5 Participants Neratinib 120 mg qd + Temsirolimus 25 mg, IV, weekly	N120 + T50 n=5 Participants Neratinib 120 mg qd + Temsirolimus 50 mg, IV, weekly	N120 + T75 n=4 Participants Neratinib 120 mg qd + Temsirolimus 75mg, IV, weekly	N160 + T15 n=4 Participants Neratinib 160 mg qd + Temsirolimus 15 mg, IV, weekly	N160 + T25 n=4 Participants Neratinib 160 mg qd + Temsirolimus 25 mg, IV, weekly	N160 + T50 n=7 Participants Neratinib 160 mg qd + Temsirolimus 50 mg, IV, weekly	N160 + T75 n=6 Participants Neratinib 160 mg qd + Temsirolimus 75 mg, IV, weekly	N200 + T15 n=5 Participants Neratinib 200 mg qd + Temsirolimus 15 mg, IV, weekly	N200 + T25 n=8 Participants Neratinib 200 mg qd + Temsirolimus 25 mg, IV, weekly	N200 + T50 n=5 Participants Neratinib 200 mg qd + Temsirolimus 50 mg, IV, weekly	N240 + T15 n=4 Participants Neratinib 240 mg qd + Temsirolimus 15 mg, IV, weekly	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	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	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	6 Participants n=115 Participants	5 Participants n=6 Participants	3 Participants n=6 Participants	7 Participants n=64 Participants	5 Participants n=17 Participants	4 Participants n=21 Participants	52 Participants n=22 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants	1 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	8 Participants n=22 Participants
Age, Continuous	50.00 years STANDARD_DEVIATION 26.15 • n=5 Participants	58.60 years STANDARD_DEVIATION 10.26 • n=7 Participants	43.00 years STANDARD_DEVIATION 16.40 • n=5 Participants	49.50 years STANDARD_DEVIATION 7.94 • n=4 Participants	49.75 years STANDARD_DEVIATION 4.79 • n=21 Participants	49.75 years STANDARD_DEVIATION 5.68 • n=10 Participants	49.29 years STANDARD_DEVIATION 12.20 • n=115 Participants	53.17 years STANDARD_DEVIATION 11.62 • n=6 Participants	59.60 years STANDARD_DEVIATION 10.62 • n=6 Participants	44.50 years STANDARD_DEVIATION 18.72 • n=64 Participants	50.00 years STANDARD_DEVIATION 7.00 • n=17 Participants	56.75 years STANDARD_DEVIATION 5.74 • n=21 Participants	50.82 years STANDARD_DEVIATION 12.70 • n=22 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=10 Participants	4 Participants n=115 Participants	5 Participants n=6 Participants	4 Participants n=6 Participants	3 Participants n=64 Participants	4 Participants n=17 Participants	4 Participants n=21 Participants	40 Participants n=22 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	5 Participants n=64 Participants	1 Participants n=17 Participants	0 Participants n=21 Participants	20 Participants n=22 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Asian	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	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	1 Participants n=17 Participants	1 Participants n=21 Participants	2 Participants n=22 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	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Black or African American	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	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	1 Participants n=22 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	4 Participants n=115 Participants	3 Participants n=6 Participants	2 Participants n=6 Participants	2 Participants n=64 Participants	3 Participants n=17 Participants	1 Participants n=21 Participants	26 Participants n=22 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	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=10 Participants	3 Participants n=115 Participants	3 Participants n=6 Participants	3 Participants n=6 Participants	5 Participants n=64 Participants	1 Participants n=17 Participants	2 Participants n=21 Participants	31 Participants n=22 Participants

PRIMARY outcome

Timeframe: From first dose date to day 28

Population: Evaluable subjects for the Maximum Tolerated Dose (MTD) contour estimation were those who either experienced a DLT within the first 28 days, regardless of the number of doses of treatment received, or received at least 21 doses of neratinib and at least 2 doses of Temsirolimus in the first 28 days of treatment.

Outcome measures

Outcome measures
Measure	Neratinib 120 mg n=14 Participants Neratinib 120 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 160 mg n=20 Participants Neratinib 160 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 200 mg n=13 Participants Neratinib 200 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 240 mg n=4 Participants Neratinib 240 mg/day with indicated level of Temsirolimus, weekly, IV.	N160 + T15 Neratinib 160 mg qd + Temsirolimus 15 mg, IV, weekly	N160 + T25 Neratinib 160 mg qd + Temsirolimus 25 mg, IV, weekly	N160 + T50 Neratinib 160 mg qd + Temsirolimus 50 mg, IV, weekly	N160 + T75 Neratinib 160 mg qd + Temsirolimus 75 mg, IV, weekly	N200 + T15 Neratinib 200 mg qd + Temsirolimus 15 mg, IV, weekly	N200 + T25 Neratinib 200 mg qd + Temsirolimus 25 mg, IV, weekly	N200 + T50 Neratinib 200 mg qd + Temsirolimus 50 mg, IV, weekly	N240 + T15 Neratinib 240 mg qd + Temsirolimus 15 mg, IV, weekly
Probability of Dose-Limiting Toxicity (DLT) Temsirolimus 15 mg	0 percent probability	12.5 percent probability	12.5 percent probability	50 percent probability	—	—	—	—	—	—	—	—
Probability of Dose-Limiting Toxicity (DLT) Temsirolimus 25 mg	13.63 percent probability	13.64 percent probability	12.5 percent probability	—	—	—	—	—	—	—	—	—
Probability of Dose-Limiting Toxicity (DLT) Temsirolimus 50 mg	13.63 percent probability	13.64 percent probability	100 percent probability	—	—	—	—	—	—	—	—	—
Probability of Dose-Limiting Toxicity (DLT) Temsirolimus 75 mg	13.63 percent probability	50 percent probability	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From first dose date to day 28

Population: Evaluable subjects were those that either experienced a dose limiting toxicity within the first 28 days, regardless of the number of doses of treatment received, or those that received at least 21 doses of neratinib and at least 2 doses of Temsirolimus in the first 28 days of treatment at the original dose level prescribed.

Identification of the daily neratinib high-dose MTD in combination with weekly temsirolimus.

Outcome measures

Outcome measures
Measure	Neratinib 120 mg n=51 Participants Neratinib 120 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 160 mg Neratinib 160 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 200 mg Neratinib 200 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 240 mg Neratinib 240 mg/day with indicated level of Temsirolimus, weekly, IV.	N160 + T15 Neratinib 160 mg qd + Temsirolimus 15 mg, IV, weekly	N160 + T25 Neratinib 160 mg qd + Temsirolimus 25 mg, IV, weekly	N160 + T50 Neratinib 160 mg qd + Temsirolimus 50 mg, IV, weekly	N160 + T75 Neratinib 160 mg qd + Temsirolimus 75 mg, IV, weekly	N200 + T15 Neratinib 200 mg qd + Temsirolimus 15 mg, IV, weekly	N200 + T25 Neratinib 200 mg qd + Temsirolimus 25 mg, IV, weekly	N200 + T50 Neratinib 200 mg qd + Temsirolimus 50 mg, IV, weekly	N240 + T15 Neratinib 240 mg qd + Temsirolimus 15 mg, IV, weekly
Maximum Tolerated Dose (MTD) of Neratinib in Combination With Temsirolimus	200 mg	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From first dose date to day 28

Population: Evaluable subjects include those that either experienced a dose limiting toxicity within the first 28 days, regardless of the number of doses of treatment received, or those that received at least 21 doses of neratinib and at least 2 doses of Temsirolimus in the first 28 days of treatment at the original dose level prescribed.

Identification of the weekly temsirolimus high-dose MTD in combination with daily neratinib

Outcome measures

Outcome measures
Measure	Neratinib 120 mg n=51 Participants Neratinib 120 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 160 mg Neratinib 160 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 200 mg Neratinib 200 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 240 mg Neratinib 240 mg/day with indicated level of Temsirolimus, weekly, IV.	N160 + T15 Neratinib 160 mg qd + Temsirolimus 15 mg, IV, weekly	N160 + T25 Neratinib 160 mg qd + Temsirolimus 25 mg, IV, weekly	N160 + T50 Neratinib 160 mg qd + Temsirolimus 50 mg, IV, weekly	N160 + T75 Neratinib 160 mg qd + Temsirolimus 75 mg, IV, weekly	N200 + T15 Neratinib 200 mg qd + Temsirolimus 15 mg, IV, weekly	N200 + T25 Neratinib 200 mg qd + Temsirolimus 25 mg, IV, weekly	N200 + T50 Neratinib 200 mg qd + Temsirolimus 50 mg, IV, weekly	N240 + T15 Neratinib 240 mg qd + Temsirolimus 15 mg, IV, weekly
Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Neratinib	50 mg	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From first dose date to day 21

A DLT was defined as any dose-limiting adverse event (AE) related to neratinib + TEMSR as follows: \[1\] Grade 3 or 4 nonhematologic toxicity (Grade 3 or 4 nausea, vomiting, hyperglycemia, hypophosphatemia, hypertriglyceridemia, or hypercholesterolemia was not considered a DLT unless the subject was already receiving optimal medical therapy). \[2\] Grade 3 or 4 diarrhea lasting \>2 days while subject was on optimal vigorous antidiarrheal therapy. \[3\] Grade 4 neutropenia lasting \>3 days or Grade 3 or 4 neutropenia of any duration with sepsis or a fever \>38.5C. \[4\] Platelet value less than or equal to 25,000/mm3 or bleeding requiring a platelet transfusion. \[5\] Delayed recovery from toxicity, which delayed rescheduled re-treatment for \>3 weeks. \[6\] Inability to maintain the original dose during the first 28 days of treatment (at least 21 doses of neratinib and 2 doses of TEMSR at the original specified dose) due to treatment-related toxicity.

Outcome measures

Outcome measures
Measure	Neratinib 120 mg n=3 Participants Neratinib 120 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 160 mg n=5 Participants Neratinib 160 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 200 mg n=5 Participants Neratinib 200 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 240 mg n=4 Participants Neratinib 240 mg/day with indicated level of Temsirolimus, weekly, IV.	N160 + T15 n=4 Participants Neratinib 160 mg qd + Temsirolimus 15 mg, IV, weekly	N160 + T25 n=4 Participants Neratinib 160 mg qd + Temsirolimus 25 mg, IV, weekly	N160 + T50 n=7 Participants Neratinib 160 mg qd + Temsirolimus 50 mg, IV, weekly	N160 + T75 n=6 Participants Neratinib 160 mg qd + Temsirolimus 75 mg, IV, weekly	N200 + T15 n=5 Participants Neratinib 200 mg qd + Temsirolimus 15 mg, IV, weekly	N200 + T25 n=8 Participants Neratinib 200 mg qd + Temsirolimus 25 mg, IV, weekly	N200 + T50 n=5 Participants Neratinib 200 mg qd + Temsirolimus 50 mg, IV, weekly	N240 + T15 n=4 Participants Neratinib 240 mg qd + Temsirolimus 15 mg, IV, weekly
Adverse Events Causing Dose Limiting Toxicities	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	3 Participants	0 Participants	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: From first dose date to progression/death or last tumor assessment, up to 30 months

Population: Subjects who completed at least 1 tumor assessment post-baseline after starting treatment and received sufficient drug (\>= 21 doses of neratinib and \>= 2 doses of temsirolimus in the first 28 days unless the subject discontinued treatment early for documented progression or symptomatic deterioration after taking at least 1 dose of test article\[s\])

The best overall response was described using the data as reported by study center investigators per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by 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. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Neratinib 120 mg n=13 Participants Neratinib 120 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 160 mg n=18 Participants Neratinib 160 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 200 mg n=10 Participants Neratinib 200 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 240 mg n=4 Participants Neratinib 240 mg/day with indicated level of Temsirolimus, weekly, IV.	N160 + T15 Neratinib 160 mg qd + Temsirolimus 15 mg, IV, weekly	N160 + T25 Neratinib 160 mg qd + Temsirolimus 25 mg, IV, weekly	N160 + T50 Neratinib 160 mg qd + Temsirolimus 50 mg, IV, weekly	N160 + T75 Neratinib 160 mg qd + Temsirolimus 75 mg, IV, weekly	N200 + T15 Neratinib 200 mg qd + Temsirolimus 15 mg, IV, weekly	N200 + T25 Neratinib 200 mg qd + Temsirolimus 25 mg, IV, weekly	N200 + T50 Neratinib 200 mg qd + Temsirolimus 50 mg, IV, weekly	N240 + T15 Neratinib 240 mg qd + Temsirolimus 15 mg, IV, weekly
Best Overall Response Complete Response	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Best Overall Response Partial Response	1 Participants	3 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Best Overall Response Stable Disease	8 Participants	11 Participants	6 Participants	1 Participants	—	—	—	—	—	—	—	—
Best Overall Response Progressive Disease	3 Participants	3 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Best Overall Response Unknown	0 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose date to progression/death or last tumor assessment, up to 30 months

Percentage of subjects with a complete response, partial response, or stable disease \>= 24 weeks, as determined by investigator assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by 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. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Neratinib 120 mg n=13 Participants Neratinib 120 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 160 mg n=18 Participants Neratinib 160 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 200 mg n=10 Participants Neratinib 200 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 240 mg n=4 Participants Neratinib 240 mg/day with indicated level of Temsirolimus, weekly, IV.	N160 + T15 Neratinib 160 mg qd + Temsirolimus 15 mg, IV, weekly	N160 + T25 Neratinib 160 mg qd + Temsirolimus 25 mg, IV, weekly	N160 + T50 Neratinib 160 mg qd + Temsirolimus 50 mg, IV, weekly	N160 + T75 Neratinib 160 mg qd + Temsirolimus 75 mg, IV, weekly	N200 + T15 Neratinib 200 mg qd + Temsirolimus 15 mg, IV, weekly	N200 + T25 Neratinib 200 mg qd + Temsirolimus 25 mg, IV, weekly	N200 + T50 Neratinib 200 mg qd + Temsirolimus 50 mg, IV, weekly	N240 + T15 Neratinib 240 mg qd + Temsirolimus 15 mg, IV, weekly
Clinical Benefit Rate	38.5 percentage of participants Interval 13.86 to 68.42	27.8 percentage of participants Interval 9.69 to 53.48	20.0 percentage of participants Interval 2.52 to 55.61	25.0 percentage of participants Interval 0.63 to 80.59	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose date to progression/death or last tumor assessment, up to 30 months

Population: Subjects who completed at least 1 tumor assessment post-baseline after starting treatment and received sufficient drug (\>= 21 doses of neratinib and \>= 2 doses of Temsirolimus in the first 28 days unless the subject discontinued treatment early for documented progression or symptomatic deterioration after taking at least 1 dose of test article\[s\])

Percentage of subjects with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by 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. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Neratinib 120 mg n=13 Participants Neratinib 120 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 160 mg n=18 Participants Neratinib 160 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 200 mg n=10 Participants Neratinib 200 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 240 mg n=4 Participants Neratinib 240 mg/day with indicated level of Temsirolimus, weekly, IV.	N160 + T15 Neratinib 160 mg qd + Temsirolimus 15 mg, IV, weekly	N160 + T25 Neratinib 160 mg qd + Temsirolimus 25 mg, IV, weekly	N160 + T50 Neratinib 160 mg qd + Temsirolimus 50 mg, IV, weekly	N160 + T75 Neratinib 160 mg qd + Temsirolimus 75 mg, IV, weekly	N200 + T15 Neratinib 200 mg qd + Temsirolimus 15 mg, IV, weekly	N200 + T25 Neratinib 200 mg qd + Temsirolimus 25 mg, IV, weekly	N200 + T50 Neratinib 200 mg qd + Temsirolimus 50 mg, IV, weekly	N240 + T15 Neratinib 240 mg qd + Temsirolimus 15 mg, IV, weekly
Objective Response Rate	15.4 percentage of participants Interval 1.92 to 45.45	16.7 percentage of participants Interval 3.58 to 41.42	20.0 percentage of participants Interval 2.52 to 55.61	25.0 percentage of participants Interval 0.63 to 80.59	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 4

Population: Subjects who had pharmacokinetic concentrations available at the dose combination, at day 22.

Area Under the Curve tau of neratinib concentrations, collected at 2, 4, 8, and 24 hours post-neratinib administration, at the week 4 dose.

Outcome measures

Outcome measures
Measure	Neratinib 120 mg n=11 Participants Neratinib 120 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 160 mg n=15 Participants Neratinib 160 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 200 mg n=11 Participants Neratinib 200 mg/day with indicated level of Temsirolimus, weekly, IV.	Neratinib 240 mg n=9 Participants Neratinib 240 mg/day with indicated level of Temsirolimus, weekly, IV.	N160 + T15 Neratinib 160 mg qd + Temsirolimus 15 mg, IV, weekly	N160 + T25 Neratinib 160 mg qd + Temsirolimus 25 mg, IV, weekly	N160 + T50 Neratinib 160 mg qd + Temsirolimus 50 mg, IV, weekly	N160 + T75 Neratinib 160 mg qd + Temsirolimus 75 mg, IV, weekly	N200 + T15 Neratinib 200 mg qd + Temsirolimus 15 mg, IV, weekly	N200 + T25 Neratinib 200 mg qd + Temsirolimus 25 mg, IV, weekly	N200 + T50 Neratinib 200 mg qd + Temsirolimus 50 mg, IV, weekly	N240 + T15 Neratinib 240 mg qd + Temsirolimus 15 mg, IV, weekly
Area Under the Curve Tau Neratinib 240 mg	1402.37 ng*hr/mL Interval 519.81 to 2602.27	NA ng*hr/mL Dose combination not studied	NA ng*hr/mL Dose combination not studied	NA ng*hr/mL Dose combination not studied	—	—	—	—	—	—	—	—
Area Under the Curve Tau Neratinib 120 mg	390.65 ng*hr/mL Interval 181.99 to 838.56	621.20 ng*hr/mL Interval 295.2 to 1836.82	408.98 ng*hr/mL Interval 45.61 to 1034.19	477.37 ng*hr/mL Interval 188.73 to 1036.4	—	—	—	—	—	—	—	—
Area Under the Curve Tau Neratinib 160 mg	1146.53 ng*hr/mL Interval 557.94 to 2356.03	775.89 ng*hr/mL Interval 590.9 to 1232.98	640.36 ng*hr/mL Interval 378.53 to 1617.55	753.47 ng*hr/mL Interval 323.88 to 1486.12	—	—	—	—	—	—	—	—
Area Under the Curve Tau Neratinib 200 mg	1396.48 ng*hr/mL Interval 627.1 to 2256.55	357.30 ng*hr/mL Interval 33.16 to 790.08	963.19 ng*hr/mL Interval 963.19 to 963.19	NA ng*hr/mL Dose combination not studied	—	—	—	—	—	—	—	—

Adverse Events

N120 + T15

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

N120 + T25

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

N120 + T50

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

N120 + T75

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

N160 + T15

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

N160 + T25

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

N160 + T50

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

N160 + T75

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

N200 + T15

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

N200 + T25

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

N200 + T50

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

N240 + T15

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	N120 + T15 n=3 participants at risk Neratinib 120 mg qd + Temsirolimus 15 mg, IV, weekly	N120 + T25 n=6 participants at risk Neratinib 120 mg qd + Temsirolimus 25 mg, IV, weekly	N120 + T50 n=5 participants at risk Neratinib 120 mg qd + Temsirolimus 50 mg, IV, weekly	N120 + T75 n=4 participants at risk Neratinib 120 mg qd + Temsirolimus 75 mg, IV, weekly	N160 + T15 n=6 participants at risk Neratinib 160 mg qd + Temsirolimus 15 mg, IV, weekly	N160 + T25 n=4 participants at risk Neratinib 160 mg qd + Temsirolimus 25 mg, IV, weekly	N160 + T50 n=7 participants at risk Neratinib 160 mg qd + Temsirolimus 50 mg, IV, weekly	N160 + T75 n=6 participants at risk Neratinib 160 mg qd + Temsirolimus 75 mg, IV, weekly	N200 + T15 n=5 participants at risk Neratinib 200 mg qd + Temsirolimus 15 mg, IV, weekly	N200 + T25 n=8 participants at risk Neratinib 200 mg qd + Temsirolimus 25 mg, IV, weekly	N200 + T50 n=5 participants at risk Neratinib 200 mg qd + Temsirolimus 50 mg, IV, weekly	N240 + T15 n=4 participants at risk Neratinib 240 mg qd + Temsirolimus 15 mg, IV, weekly
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Cardiac disorders Supraventricular tachycardia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Congenital, familial and genetic disorders Aplasia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Colitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Gastritis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Ileus	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Nausea	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Proctitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Subileus	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Vomiting	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Mucosal inflammation	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Pyrexia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Hepatobiliary disorders Hepatocellular injury	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Device related infection	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Infection	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Lobar pneumonia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Lung abscess	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Lymphangitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Meningitis bacterial	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Oral herpes	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Pneumonia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Pyelonephritis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Pyelonephritis acute	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Urinary tract infection	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Injury, poisoning and procedural complications Overdose	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations International normalised ratio increased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Hypercreatinaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Cerebral ischaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Convulsion	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Hemianopia homonymous	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Radiculopathy	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Renal and urinary disorders Urinary retention	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Vascular disorders Venous thrombosis limb	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.

Other adverse events

Other adverse events
Measure	N120 + T15 n=3 participants at risk Neratinib 120 mg qd + Temsirolimus 15 mg, IV, weekly	N120 + T25 n=6 participants at risk Neratinib 120 mg qd + Temsirolimus 25 mg, IV, weekly	N120 + T50 n=5 participants at risk Neratinib 120 mg qd + Temsirolimus 50 mg, IV, weekly	N120 + T75 n=4 participants at risk Neratinib 120 mg qd + Temsirolimus 75 mg, IV, weekly	N160 + T15 n=6 participants at risk Neratinib 160 mg qd + Temsirolimus 15 mg, IV, weekly	N160 + T25 n=4 participants at risk Neratinib 160 mg qd + Temsirolimus 25 mg, IV, weekly	N160 + T50 n=7 participants at risk Neratinib 160 mg qd + Temsirolimus 50 mg, IV, weekly	N160 + T75 n=6 participants at risk Neratinib 160 mg qd + Temsirolimus 75 mg, IV, weekly	N200 + T15 n=5 participants at risk Neratinib 200 mg qd + Temsirolimus 15 mg, IV, weekly	N200 + T25 n=8 participants at risk Neratinib 200 mg qd + Temsirolimus 25 mg, IV, weekly	N200 + T50 n=5 participants at risk Neratinib 200 mg qd + Temsirolimus 50 mg, IV, weekly	N240 + T15 n=4 participants at risk Neratinib 240 mg qd + Temsirolimus 15 mg, IV, weekly
General disorders Fatigue	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	57.1% 4/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Granuloma	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Inflammation	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Blood triglycerides increased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Psychiatric disorders Hallucination	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	60.0% 3/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	75.0% 3/4 • From first dose through 28 days after last dose, up to 30 months.	57.1% 4/7 • From first dose through 28 days after last dose, up to 30 months.	66.7% 4/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	75.0% 3/4 • From first dose through 28 days after last dose, up to 30 months.
Blood and lymphatic system disorders Hypoprothrombinaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Blood and lymphatic system disorders Lymphopenia	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	42.9% 3/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	60.0% 3/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	42.9% 3/7 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	60.0% 3/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 4/8 • From first dose through 28 days after last dose, up to 30 months.	80.0% 4/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.
Cardiac disorders Mitral valve incompetence	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Cardiac disorders Tachycardia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Cardiac disorders Ventricular hypokinesia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Ear and labyrinth disorders Ear pain	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Ear and labyrinth disorders Ear pruritus	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.
Eye disorders Cataract	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Eye disorders Diplopia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Eye disorders Dry eye	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Eye disorders Eye irritation	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Eye disorders Eyelid function disorder	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Eye disorders Eyelid oedema	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Eye disorders Keratitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Eye disorders Ocular hyperaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Eye disorders Visual impairment	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Eye disorders Vitreous floaters	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Abdominal pain	66.7% 2/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Aerophagia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Chapped lips	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Cheilitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Colitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Constipation	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	62.5% 5/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Diarrhoea	100.0% 3/3 • From first dose through 28 days after last dose, up to 30 months.	83.3% 5/6 • From first dose through 28 days after last dose, up to 30 months.	100.0% 5/5 • From first dose through 28 days after last dose, up to 30 months.	100.0% 4/4 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	100.0% 4/4 • From first dose through 28 days after last dose, up to 30 months.	100.0% 7/7 • From first dose through 28 days after last dose, up to 30 months.	83.3% 5/6 • From first dose through 28 days after last dose, up to 30 months.	100.0% 5/5 • From first dose through 28 days after last dose, up to 30 months.	75.0% 6/8 • From first dose through 28 days after last dose, up to 30 months.	80.0% 4/5 • From first dose through 28 days after last dose, up to 30 months.	100.0% 4/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Distal ileal obstruction syndrome	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Dysphagia	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Gingival bleeding	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Glossodynia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Haematochezia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Lip dry	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Lip pain	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Mouth ulceration	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Nausea	66.7% 2/3 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	75.0% 3/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	75.0% 3/4 • From first dose through 28 days after last dose, up to 30 months.	71.4% 5/7 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	100.0% 5/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 4/8 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	75.0% 3/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Odynophagia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Oesophageal pain	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Oral mucosal erythema	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Oral pain	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Rectal haemorrhage	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Stomatitis	66.7% 2/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	60.0% 3/5 • From first dose through 28 days after last dose, up to 30 months.	75.0% 3/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	42.9% 3/7 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	62.5% 5/8 • From first dose through 28 days after last dose, up to 30 months.	60.0% 3/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Subileus	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Toothache	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	75.0% 3/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	71.4% 5/7 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	80.0% 4/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 4/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	100.0% 4/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Asthenia	66.7% 2/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	42.9% 3/7 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	60.0% 3/5 • From first dose through 28 days after last dose, up to 30 months.	62.5% 5/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Catheter site haemorrhage	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Catheter site pain	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Chest discomfort	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Chest pain	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Chills	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Influenza like illness	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Local swelling	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Malaise	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Mucosal inflammation	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	60.0% 3/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	57.1% 4/7 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	75.0% 3/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Non-cardiac chest pain	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Oedema	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Oedema peripheral	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Pyrexia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	60.0% 3/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	57.1% 4/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	62.5% 5/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Thrombosis in device	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
General disorders Xerosis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Hepatobiliary disorders Hepatocellular injury	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Hepatobiliary disorders Hyperbilirubinaemia	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Immune system disorders Hypogammaglobulinaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Botryomycosis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Bronchitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Candida infection	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Clostridium difficile colitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Conjunctivitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Cystitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Ear infection	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Ecthyma	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Erysipeloid	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Folliculitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	62.5% 5/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Gastroenteritis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Genital herpes	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Gingivitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Herpes pharyngitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Herpes virus infection	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Hordeolum	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Infection	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Laryngitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Localised infection	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Lung infection	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Lymphangitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Nasopharyngitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Oral candidiasis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Oral herpes	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Paronychia	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Pharyngitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Pneumonia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Pyelonephritis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Rash pustular	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Rhinitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	37.5% 3/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Sinusitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Tonsillitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Tooth abscess	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Tooth infection	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Urinary tract infection	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Vaginal infection	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Injury, poisoning and procedural complications Cystitis radiation	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Injury, poisoning and procedural complications Eye injury	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	60.0% 3/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Amylase increased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Blood bicarbonate decreased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Blood cholesterol increased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Blood creatine phosphokinase	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Blood creatine phosphokinase increased	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Blood creatinine increased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Blood magnesium decreased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Cardiac murmur	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Chest X-ray abnormal	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Haemoglobin decreased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations International normalised ratio increased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Lipase increased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Platelet count decreased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Troponin increased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations Weight decreased	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Investigations White blood cell count decreased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Decreased appetite	66.7% 2/3 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	75.0% 3/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	71.4% 5/7 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	60.0% 3/5 • From first dose through 28 days after last dose, up to 30 months.	37.5% 3/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	75.0% 3/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	57.1% 4/7 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	57.1% 4/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	42.9% 3/7 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	42.9% 3/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	37.5% 3/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	75.0% 3/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	75.0% 3/4 • From first dose through 28 days after last dose, up to 30 months.	42.9% 3/7 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 4/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	85.7% 6/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 4/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	100.0% 4/4 • From first dose through 28 days after last dose, up to 30 months.
Metabolism and nutrition disorders Polydipsia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Back pain	66.7% 2/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	37.5% 3/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	42.9% 3/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour embolism	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Amnesia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Dizziness	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Dysgeusia	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	75.0% 3/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	42.9% 3/7 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Dystonia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Headache	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	66.7% 4/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	60.0% 3/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 4/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Hyperaesthesia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Migraine	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Myoclonus	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Neuralgia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Paraesthesia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Sciatica	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Somnolence	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Tremor	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Nervous system disorders Vocal cord paralysis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Psychiatric disorders Anorgasmia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Psychiatric disorders Anxiety	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.
Psychiatric disorders Confusional state	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Psychiatric disorders Depression	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Psychiatric disorders Insomnia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Renal and urinary disorders Dysuria	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Renal and urinary disorders Haematuria	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Renal and urinary disorders Incontinence	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Renal and urinary disorders Micturition urgency	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Renal and urinary disorders Renal failure	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Reproductive system and breast disorders Erectile dysfunction	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Reproductive system and breast disorders Genital rash	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Reproductive system and breast disorders Penile erythema	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Reproductive system and breast disorders Scrotal oedema	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Reproductive system and breast disorders Vaginal inflammation	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Reproductive system and breast disorders Vaginal lesion	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	66.7% 4/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	57.1% 4/7 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 4/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	66.7% 4/6 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	42.9% 3/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	60.0% 3/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	42.9% 3/7 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	37.5% 3/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Sputum increased	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Acne	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Dry skin	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Eczema	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 2/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Melanoderma	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Nail dystrophy	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Nail toxicity	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Onycholysis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Prurigo	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	28.6% 2/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	37.5% 3/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	50.0% 3/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	33.3% 2/6 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	71.4% 5/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	40.0% 2/5 • From first dose through 28 days after last dose, up to 30 months.	37.5% 3/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	14.3% 1/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Skin fissures	33.3% 1/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	50.0% 2/4 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	20.0% 1/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Skin and subcutaneous tissue disorders Xeroderma	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Vascular disorders Haematoma	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Vascular disorders Haemorrhage	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Vascular disorders Hot flush	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Vascular disorders Orthostatic hypotension	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	25.0% 1/4 • From first dose through 28 days after last dose, up to 30 months.
Vascular disorders Peripheral vascular disorder	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	12.5% 1/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Vascular disorders Thrombophlebitis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.
Vascular disorders Thrombosis	0.00% 0/3 • From first dose through 28 days after last dose, up to 30 months.	16.7% 1/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/7 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/6 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/8 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/5 • From first dose through 28 days after last dose, up to 30 months.	0.00% 0/4 • From first dose through 28 days after last dose, up to 30 months.

Additional Information

Senior Director, Clinical Operations

Puma Biotechnology, Inc.

Phone: +1 (424) 248-6500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60