Trial Outcomes & Findings for Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors (NCT NCT01390818)

Last Updated: 2017-03-07

Results Overview

DLT was defined as any of the following toxicities experienced during the first cycle of treatment at any dose level (DL) and judged not to be related to the underlying disease or any concomitant medication by the Investigator and/or the Sponsor: A treatment emergent adverse event (TEAE) of potential clinical significance such that further dose escalation (DE) would have exposed subjects to unacceptable risk. Any Grade greater than or equal to (\>=) 3 non-hematological toxicity, except for: Grade 3 diarrhea, nausea and vomiting with a duration less than or equal to (\<=) 48 hours despite adequate supportive care and Alopecia. Grade 4 neutropenia of \> 5 days duration or febrile neutropenia. Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia. Any treatment interruption \> 2 weeks due to AEs not related to the underlying disease or concomitant medication at any dose level and any severe, life-threatening impairing daily functions complication or abnormality.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

146 participants

Primary outcome timeframe

Day 1 up to Day 16 in cycle 1

Results posted on

2017-03-07

Participant Flow

First subject (informed consent): May 2011. Study completion date: Apr 2015. A total of 192 subjects were screened and 146 subjects entered the trial and received the investigational medicinal product (IMP).

Study had a 4-day Drug-Drug Interaction (DDI) period, within 1 week prior to Day 1 Cycle 1, to assess possible interaction only in selected subjects where in SAR245409 and Pimasertib were administered alone on Day 1 and Day 3, respectively.

Participant milestones

Participant milestones
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (Dose Escalation \[DE\] cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Overall Study STARTED	3	3	3	4	4	3	19	14	3	3	4	26	24	18	15
Overall Study COMPLETED	3	3	3	4	4	3	19	14	3	3	4	26	24	18	15
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=19 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=14 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily n=26 Participants Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily n=24 Participants Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily n=18 Participants Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily n=15 Participants Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	Total n=146 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	16 Participants n=8 Participants	12 Participants n=24 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	22 Participants n=42 Participants	16 Participants n=36 Participants	12 Participants n=36 Participants	13 Participants n=24 Participants	107 Participants n=135 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	4 Participants n=42 Participants	8 Participants n=36 Participants	6 Participants n=36 Participants	2 Participants n=24 Participants	39 Participants n=135 Participants
Gender Female	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	6 Participants n=8 Participants	13 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	26 Participants n=42 Participants	15 Participants n=36 Participants	11 Participants n=36 Participants	4 Participants n=24 Participants	87 Participants n=135 Participants
Gender Male	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	13 Participants n=8 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants	0 Participants n=42 Participants	9 Participants n=36 Participants	7 Participants n=36 Participants	11 Participants n=24 Participants	59 Participants n=135 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 16 in cycle 1

Population: The dose escalation (DE) analysis set included all subjects treated in DE cohorts who received at least 80 percent (%) of pimasertib and 80% of SAR245409 full planned doses in the first cycle (ie, 21-day period from Day 1) of treatment or who experienced a DLT during the first cycle of treatment regardless of the received amount of each drug.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=2 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=11 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=11 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=2 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Number of Subjects With Dose Limiting Toxicities (DLT)	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects	2 subjects	1 subjects	2 subjects	1 subjects	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 30 Days after last dose; assessed up to 4 years

Population: The safety analysis set (SAF) analysis set was to include all subjects who had received at least 1 (non-zero) administration of the trial investigational medicinal products (IMPs) MSC1936369B (pimasertib) and/or SAR245409.

An adverse event (AE) was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as those AEs that started between first dose of study drug and up to 30 days after last dose.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=19 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=14 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily n=26 Participants Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily n=24 Participants Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily n=18 Participants Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily n=15 Participants Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Number of Subjects Experiencing Any Treatment-Emergent Adverse Events (TEAEs)	3 subjects	3 subjects	3 subjects	4 subjects	4 subjects	3 subjects	19 subjects	14 subjects	3 subjects	3 subjects	4 subjects	26 subjects	24 subjects	18 subjects	15 subjects

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The pharmacokinetic (PK) analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=10 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=14 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=24 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=18 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Maximum Observed Plasma Concentration (Cmax) for Pimasertib (MSC1936369B) Day 15 (n=6, 9,15,9, 3, 1, 16, 17, 13, 10)	131.3 nanogram/millilitre (ng/mL) Interval 85.13 to 202.6	212.8 nanogram/millilitre (ng/mL) Interval 178.9 to 253.1	234.2 nanogram/millilitre (ng/mL) Interval 166.2 to 330.1	516.4 nanogram/millilitre (ng/mL) Interval 375.0 to 711.0	143.1 nanogram/millilitre (ng/mL) Interval 22.82 to 897.8	NA nanogram/millilitre (ng/mL) Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	320.5 nanogram/millilitre (ng/mL) Interval 286.2 to 358.9	327.6 nanogram/millilitre (ng/mL) Interval 248.5 to 431.9	307.7 nanogram/millilitre (ng/mL) Interval 205.0 to 461.8	338.9 nanogram/millilitre (ng/mL) Interval 281.0 to 408.8	—	—	—	—	—
Maximum Observed Plasma Concentration (Cmax) for Pimasertib (MSC1936369B) Day 1 (n=6, 10, 26, 13, 4, 3, 25, 23, 18, 15)	86.06 nanogram/millilitre (ng/mL) Interval 51.31 to 144.3	188.2 nanogram/millilitre (ng/mL) Interval 138.5 to 255.9	246.1 nanogram/millilitre (ng/mL) Interval 191.8 to 315.6	406.9 nanogram/millilitre (ng/mL) Interval 284.6 to 581.7	83.72 nanogram/millilitre (ng/mL) Interval 18.05 to 388.3	232.5 nanogram/millilitre (ng/mL) Interval 190.9 to 283.2	323.1 nanogram/millilitre (ng/mL) Interval 253.9 to 411.1	295.4 nanogram/millilitre (ng/mL) Interval 240.9 to 362.2	245.6 nanogram/millilitre (ng/mL) Interval 198.5 to 304.0	234.0 nanogram/millilitre (ng/mL) Interval 182.6 to 299.8	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=10 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=14 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=24 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=18 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Time to Reach Maximum Plasma Concentration (Tmax) of Pimasertib (MSC1936369B) Day 15 (n= 6, 9, 15, 9, 3, 1, 16, 17, 13, 10)	1.275 hour Interval 0.5 to 3.07	1.000 hour Interval 1.0 to 1.63	2.000 hour Interval 1.0 to 7.95	1.550 hour Interval 1.0 to 2.0	2.000 hour Interval 1.5 to 4.17	NA hour Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	1.505 hour Interval 0.53 to 3.0	1.530 hour Interval 1.0 to 4.0	1.500 hour Interval 0.5 to 8.0	1.030 hour Interval 0.48 to 3.83	—	—	—	—	—
Time to Reach Maximum Plasma Concentration (Tmax) of Pimasertib (MSC1936369B) Day 1 (n= 6, 10, 25, 13, 4, 3, 25, 23, 18, 15 )	1.750 hour Interval 0.5 to 2.08	0.765 hour Interval 0.5 to 2.15	2.020 hour Interval 0.5 to 8.05	1.500 hour Interval 0.5 to 3.0	1.485 hour Interval 0.5 to 2.08	1.550 hour Interval 0.5 to 2.07	1.500 hour Interval 0.5 to 7.9	1.520 hour Interval 0.5 to 7.85	1.490 hour Interval 0.5 to 4.2	1.050 hour Interval 0.45 to 4.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set . Here "n" signifies the number of subjects evaluable at the specific time points.

Area under the concentration-time curve from time 0 to the last quantifiable concentration.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=10 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=14 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=24 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=18 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of Pimasertib (MSC1936369B) Day 1 (n=6, 10, 25, 13, 4, 3, 25, 23, 18, 15)	426.8 hournanogram per millilitre (hrng/mL) Interval 306.2 to 594.9	734.4 hournanogram per millilitre (hrng/mL) Interval 586.1 to 920.3	1547 hournanogram per millilitre (hrng/mL) Interval 1238.0 to 1934.0	2116 hournanogram per millilitre (hrng/mL) Interval 1664.0 to 2692.0	326.1 hournanogram per millilitre (hrng/mL) Interval 110.9 to 958.7	1252 hournanogram per millilitre (hrng/mL) Interval 1100.0 to 1425.0	1781 hournanogram per millilitre (hrng/mL) Interval 1404.0 to 2260.0	1754 hournanogram per millilitre (hrng/mL) Interval 1480.0 to 2078.0	1709 hournanogram per millilitre (hrng/mL) Interval 1361.0 to 2146.0	1093 hournanogram per millilitre (hrng/mL) Interval 871.5 to 1371.0	—	—	—	—	—
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of Pimasertib (MSC1936369B) Day 15 (n=6, 9,15,9, 3, 1, 16, 17, 10, 13)	625.3 hournanogram per millilitre (hrng/mL) Interval 405.7 to 963.9	902.0 hournanogram per millilitre (hrng/mL) Interval 747.6 to 1088.0	1617 hournanogram per millilitre (hrng/mL) Interval 1170.0 to 2236.0	2552 hournanogram per millilitre (hrng/mL) Interval 2185.0 to 2980.0	773.1 hournanogram per millilitre (hrng/mL) Interval 201.0 to 2974.0	NA hournanogram per millilitre (hrng/mL) Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	2136 hournanogram per millilitre (hrng/mL) Interval 1713.0 to 2663.0	1889 hournanogram per millilitre (hrng/mL) Interval 1540.0 to 2318.0	1988 hournanogram per millilitre (hrng/mL) Interval 1487.0 to 2658.0	1506 hournanogram per millilitre (hrng/mL) Interval 1141.0 to 1988.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts

Population: The PK analysis set. Here "N" signifies the number of subjects evaluable for this outcome measure. Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of AUCinf.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=9 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=23 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=13 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=22 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=22 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=14 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=13 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of Pimasertib (MSC1936369B) at Day 1	451.6 hr*ng/mL Interval 319.8 to 637.8	770.9 hr*ng/mL Interval 599.9 to 990.6	1607 hr*ng/mL Interval 1237.0 to 2087.0	2202 hr*ng/mL Interval 1716.0 to 2826.0	503.1 hr*ng/mL Interval 153.1 to 1654.0	—	1869 hr*ng/mL Interval 1451.0 to 2407.0	1830 hr*ng/mL Interval 1518.0 to 2207.0	1857 hr*ng/mL Interval 1414.0 to 2437.0	1113 hr*ng/mL Interval 858.9 to 1442.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=10 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=14 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=24 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=18 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of Pimasertib (MSC1936369B) Day 15 (n=6, 9, 15, 9, 3, 0, 16, 17, 10, 13)	650.4 hr*ng/mL Interval 440.1 to 961.2	902.0 hr*ng/mL Interval 747.6 to 1088.0	1617 hr*ng/mL Interval 1170.0 to 2236.0	2552 hr*ng/mL Interval 2185.0 to 2980.0	773.1 hr*ng/mL Interval 201.0 to 2974.0	NA hr*ng/mL Data could not be calculated because there were no subjects evaluated for this arm at the specified time point.	2136 hr*ng/mL Interval 1713.0 to 2663.0	1889 hr*ng/mL Interval 1540.0 to 2318.0	1988 hr*ng/mL Interval 1487.0 to 2658.0	1506 hr*ng/mL Interval 1141.0 to 1988.0	—	—	—	—	—
Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of Pimasertib (MSC1936369B) Day 1 (n= 6, 10, 26, 13, 3, 3, 24, 23, 17,13)	426.8 hr*ng/mL Interval 306.2 to 594.9	742.1 hr*ng/mL Interval 602.0 to 914.7	1547 hr*ng/mL Interval 1238.0 to 1934.0	2116 hr*ng/mL Interval 1664.0 to 2692.0	354.9 hr*ng/mL Interval 48.21 to 2613.0	1252 hr*ng/mL Interval 1100.0 to 1425.0	1882 hr*ng/mL Interval 1513.0 to 2341.0	1754 hr*ng/mL Interval 1480.0 to 2078.0	1772 hr*ng/mL Interval 1409.0 to 2227.0	1093 hr*ng/mL Interval 871.5 to 1371.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=10 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=14 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=24 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=18 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Half-Life (t1/2) of MSC1936369B (Pimasertib) Day 1 (n=6, 9, 23, 13, 4, 3, 22, 22, 15, 13)	6.250 hour Interval 5.03 to 7.16	4.670 hour Interval 1.85 to 5.79	4.840 hour Interval 3.23 to 9.99	4.800 hour Interval 3.49 to 7.62	3.320 hour Interval 2.6 to 4.72	4.640 hour Interval 4.25 to 4.74	4.840 hour Interval 2.46 to 8.41	4.370 hour Interval 3.71 to 8.26	4.770 hour Interval 3.51 to 12.8	4.240 hour Interval 3.32 to 4.84	—	—	—	—	—
Half-Life (t1/2) of MSC1936369B (Pimasertib) Day 15 (n=6, 9, 14, 9, 2, 1, 16, 16, 9, 12)	5.855 hour Interval 2.93 to 7.88	5.410 hour Interval 3.9 to 10.8	6.755 hour Interval 4.61 to 14.3	5.590 hour Interval 3.97 to 14.1	NA hour Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	NA hour Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	5.210 hour Interval 3.25 to 12.8	5.250 hour Interval 4.33 to 8.65	5.210 hour Interval 4.8 to 6.94	4.325 hour Interval 3.4 to 5.96	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set. Here "N" signifies number of subjects evaluable for this outcome measure and "n" signifies the number of subjects evaluable at the specific time points.

The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the Dose with area under the plasma concentration time curve from time zero to infinity (AUC0 inf)=Dose/AUC0- inf.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=10 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=14 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=24 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=18 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Total Body Clearance (CL/f) of Pimasertib (MSC1936369B) Day 15 (n=6, 9, 15, 9, 3, 1, 16, 17, 10, 13)	23.06 litre per hour (L/hr) Interval 15.59 to 34.1	33.30 litre per hour (L/hr) Interval 27.63 to 40.13	37.11 litre per hour (L/hr) Interval 26.82 to 51.33	35.28 litre per hour (L/hr) Interval 30.19 to 41.23	58.22 litre per hour (L/hr) Interval 15.03 to 225.6	NA litre per hour (L/hr) Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	28.11 litre per hour (L/hr) Interval 22.54 to 35.07	31.73 litre per hour (L/hr) Interval 25.85 to 38.94	30.20 litre per hour (L/hr) Interval 22.59 to 40.38	39.81 litre per hour (L/hr) Interval 30.17 to 52.52	—	—	—	—	—
Total Body Clearance (CL/f) of Pimasertib (MSC1936369B) Day 1 (n=6, 10, 26, 13, 3, 0, 22, 22, 14, 13)	33.22 litre per hour (L/hr) Interval 23.52 to 46.92	38.90 litre per hour (L/hr) Interval 30.26 to 50.0	37.99 litre per hour (L/hr) Interval 29.33 to 49.22	40.88 litre per hour (L/hr) Interval 31.85 to 52.47	89.49 litre per hour (L/hr) Interval 27.14 to 295.1	NA litre per hour (L/hr) Data could not be calculated because there were no subjects evaluated for this arm at the specified time point.	32.12 litre per hour (L/hr) Interval 24.95 to 41.36	32.75 litre per hour (L/hr) Interval 27.16 to 39.5	30.75 litre per hour (L/hr) Interval 23.41 to 40.41	53.94 litre per hour (L/hr) Interval 41.61 to 69.62	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set. Here "N" signifies number of subjects evaluable for this outcome measure and "n" signifies the number of subjects evaluable at specific time points.

Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Apparent volume of distribution during the terminal phase, calculated by CL/f/λz. Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of Vz/f.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=10 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=14 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=24 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=18 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Apparent Volume of Distribution of Total Pimasertib During the Terminal Phase Following Oral Administration (Vz/f) of Pimasertib Day 1 (n=6, 9, 23, 13, 3, 0, 22, 22, 14, 13)	294.3 liter Interval 218.5 to 396.4	240.2 liter Interval 202.5 to 284.9	282.8 liter Interval 227.7 to 351.4	283.0 liter Interval 224.0 to 357.6	394.1 liter Interval 146.9 to 1058.0	—	223.8 liter Interval 182.7 to 274.3	226.9 liter Interval 193.9 to 265.4	216.2 liter Interval 174.6 to 267.8	322.0 liter Interval 251.5 to 412.3	—	—	—	—	—
Apparent Volume of Distribution of Total Pimasertib During the Terminal Phase Following Oral Administration (Vz/f) of Pimasertib Day 15 (n=6, 9, 13, 9, 0, 0, 16, 16, 9, 12)	188.7 liter Interval 133.4 to 266.9	261.8 liter Interval 187.9 to 364.8	396.4 liter Interval 276.9 to 567.3	302.4 liter Interval 223.1 to 409.7	NA liter Data could not be calculated because there were no subjects evaluated for this arm at the specified time point because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of Vz/f.	—	226.3 liter Interval 189.7 to 270.1	250.9 liter Interval 214.2 to 293.9	230.6 liter Interval 169.0 to 314.6	273.8 liter Interval 213.8 to 350.7	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set. Here "N" signifies number of subjects evaluable for this outcome measure and "n" signifies the number of subjects evaluable at the specific time points.

Accumulation ratio (Racc) for AUCtau, calculated as Day 15 dosing interval AUCtau per Day 1 dosing interval AUCtau.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=9 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=9 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=17 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=10 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=13 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Accumulation Ratio (Racc) for AUCtau of Pimasertib (MSC1936369B): Day 15	1.523 ratio Interval 1.295 to 1.792	1.269 ratio Interval 1.107 to 1.455	1.174 ratio Interval 0.9326 to 1.479	1.364 ratio Interval 1.133 to 1.642	2.176 ratio Interval 0.1184 to 39.99	NA ratio Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	1.368 ratio Interval 1.044 to 1.792	1.155 ratio Interval 1.004 to 1.33	1.245 ratio Interval 0.9538 to 1.625	1.283 ratio Interval 1.104 to 1.49	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set. Here "N" signifies number of subjects evaluable for this outcome measure and "n" signifies the number of subjects evaluable at the specific time points.

Accumulation ratio (Racc) for Cmax, calculated as Day 15 Cmax/Day 1 Cmax.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=9 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=9 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=16 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=17 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=10 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=13 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Accumulation Ratio (Racc) for Cmax of Pimasertib (MSC1936369B): Day 15	1.525 ratio Interval 1.002 to 2.322	1.066 ratio Interval 0.7442 to 1.527	1.106 ratio Interval 0.7904 to 1.546	1.308 ratio Interval 0.7537 to 2.268	1.467 ratio Interval 0.02541 to 84.67	NA ratio Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	1.203 ratio Interval 0.9074 to 1.595	1.059 ratio Interval 0.8875 to 1.263	1.247 ratio Interval 0.8719 to 1.784	1.393 ratio Interval 1.091 to 1.78	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=11 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=36 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=24 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=18 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Maximum Observed Plasma Concentration (Cmax) for SAR245409 Day 1 (n=6, 11, 36, 3, 3, 4, 26, 23, 18, 15)	192.0 nanogram per millilitre (ng/mL) Interval 115.6 to 316.3	295.7 nanogram per millilitre (ng/mL) Interval 189.0 to 462.6	256.9 nanogram per millilitre (ng/mL) Interval 203.5 to 324.3	224.5 nanogram per millilitre (ng/mL) Interval 99.72 to 505.2	130.2 nanogram per millilitre (ng/mL) Interval 20.76 to 816.5	64.22 nanogram per millilitre (ng/mL) Interval 19.25 to 214.2	323.6 nanogram per millilitre (ng/mL) Interval 258.4 to 405.2	240.6 nanogram per millilitre (ng/mL) Interval 164.6 to 351.6	239.6 nanogram per millilitre (ng/mL) Interval 158.8 to 361.4	212.5 nanogram per millilitre (ng/mL) Interval 129.3 to 349.4	—	—	—	—	—
Maximum Observed Plasma Concentration (Cmax) for SAR245409 Day 15 (n=6, 6, 25, 1, 1, 3, 17, 17, 10, 13)	199.8 nanogram per millilitre (ng/mL) Interval 114.4 to 349.1	224.1 nanogram per millilitre (ng/mL) Interval 132.7 to 378.4	222.9 nanogram per millilitre (ng/mL) Interval 143.7 to 345.7	NA nanogram per millilitre (ng/mL) Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	NA nanogram per millilitre (ng/mL) Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	117.2 nanogram per millilitre (ng/mL) Interval 7.21 to 1907.0	326.0 nanogram per millilitre (ng/mL) Interval 256.4 to 414.6	235.5 nanogram per millilitre (ng/mL) Interval 144.6 to 383.3	178.9 nanogram per millilitre (ng/mL) Interval 82.31 to 389.0	226.6 nanogram per millilitre (ng/mL) Interval 143.9 to 356.7	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.

The time to reach maximum plasma concentration (Tmax) of SAR245409 was calculated.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=11 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=36 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=24 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=18 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Time to Reach Maximum Plasma Concentration (Tmax) of SAR245409 Day 15 (n=6, 8, 25, 1, 1, 3, 17, 17, 10, 13)	1.265 hours Interval 1.0 to 2.0	1.750 hours Interval 0.53 to 3.0	1.970 hours Interval 1.0 to 8.13	NA hours Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	NA hours Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	1.550 hours Interval 1.5 to 8.0	2.030 hours Interval 0.52 to 7.98	1.530 hours Interval 0.92 to 8.0	1.750 hours Interval 0.5 to 8.0	1.050 hours Interval 0.5 to 3.97	—	—	—	—	—
Time to Reach Maximum Plasma Concentration (Tmax) of SAR245409 Day 1 (n=6, 11, 36, 3, 3, 4, 26, 23, 18, 15)	1.510 hours Interval 0.53 to 2.08	1.150 hours Interval 0.5 to 4.1	1.500 hours Interval 0.5 to 23.8	1.500 hours Interval 1.0 to 8.0	2.050 hours Interval 1.5 to 2.07	1.540 hours Interval 0.5 to 4.0	1.500 hours Interval 0.52 to 8.03	2.000 hours Interval 0.5 to 4.17	2.000 hours Interval 0.43 to 8.05	1.500 hours Interval 0.95 to 4.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.

Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time (0-24 hours) at which the concentration is at or above the lower limit of quantification. Unit of assessment was hour\*nanogram per milliliter (hr\*ng/mL).

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=11 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=36 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=24 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=18 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of SAR245409 Day 1 (n=6, 11, 36, 3, 3, 4, 26, 23, 18, 15)	683.6 hr*ng/mL Interval 248.9 to 1878.0	1248 hr*ng/mL Interval 760.1 to 2050.0	1566 hr*ng/mL Interval 1162.0 to 2111.0	3032 hr*ng/mL Interval 1425.0 to 6454.0	634.0 hr*ng/mL Interval 111.8 to 3595.0	226.2 hr*ng/mL Interval 82.99 to 616.7	1976 hr*ng/mL Interval 1449.0 to 2693.0	1408 hr*ng/mL Interval 962.5 to 2059.0	1479 hr*ng/mL Interval 824.6 to 2653.0	854.9 hr*ng/mL Interval 505.0 to 1447.0	—	—	—	—	—
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of SAR245409 Day 15 (n=6, 8, 25, 1, 1, 3, 17, 17, 10, 13)	861.0 hr*ng/mL Interval 371.5 to 1995.0	1125 hr*ng/mL Interval 558.3 to 2266.0	1334 hr*ng/mL Interval 895.8 to 1986.0	NA hr*ng/mL Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	NA hr*ng/mL Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	537.5 hr*ng/mL Interval 56.1 to 5150.0	2232 hr*ng/mL Interval 1512.0 to 3297.0	1437 hr*ng/mL Interval 922.1 to 2239.0	1365 hr*ng/mL Interval 543.4 to 3431.0	968.8 hr*ng/mL Interval 554.8 to 1692.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=11 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=36 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=24 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=18 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of SAR245409 Day 1 (n=6, 11, 36, 3, 3, 3, 24, 23, 17, 15)	746.9 hr*ng/mL Interval 275.5 to 2024.0	1265 hr*ng/mL Interval 784.5 to 2041.0	1601 hr*ng/mL Interval 1195.0 to 2145.0	3032 hr*ng/mL Interval 1425.0 to 6454.0	634.0 hr*ng/mL Interval 111.8 to 3595.0	298.6 hr*ng/mL Interval 120.4 to 740.6	2115 hr*ng/mL Interval 1535.0 to 2915.0	1480 hr*ng/mL Interval 1026.0 to 2137.0	1542 hr*ng/mL Interval 851.5 to 2792.0	948.4 hr*ng/mL Interval 601.8 to 1495.0	—	—	—	—	—
Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of SAR245409 Day 15 (n=6, 8, 25, 1, 1, 3, 17, 17, 10, 13)	887.9 hr*ng/mL Interval 397.9 to 1981.0	1168 hr*ng/mL Interval 611.5 to 2232.0	1362 hr*ng/mL Interval 918.9 to 2018.0	NA hr*ng/mL Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	NA hr*ng/mL Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	537.5 hr*ng/mL Interval 56.1 to 5150.0	2390 hr*ng/mL Interval 1696.0 to 3368.0	1437 hr*ng/mL Interval 922.1 to 2239.0	1365 hr*ng/mL Interval 543.4 to 3431.0	1074 hr*ng/mL Interval 636.9 to 1811.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts

Population: The PK analysis set. Here "N" signifies number of subjects evaluable for this outcome measure and "n" signifies the number of subjects evaluable at the specific time points.

Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC0-t + last observed concentration (Clast)/terminal rate constant (λz), using the Linear up/Log down method. Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=5 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=9 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=31 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=2 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=20 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=17 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=12 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=12 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Infinity (0-inf) of SAR245409: Day 1	716.5 hr*ng/mL Interval 181.8 to 2823.0	1165 hr*ng/mL Interval 648.3 to 2093.0	1504 hr*ng/mL Interval 1113.0 to 2034.0	NA hr*ng/mL Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	NA hr*ng/mL Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	331.2 hr*ng/mL Interval 151.5 to 724.1	1974 hr*ng/mL Interval 1408.0 to 2768.0	1445 hr*ng/mL Interval 1019.0 to 2049.0	1261 hr*ng/mL Interval 579.4 to 2743.0	1142 hr*ng/mL Interval 750.4 to 1739.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=11 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=36 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=24 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=18 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Apparent Terminal Half-Life (t1/2) of SAR245409 Day 1 (n=6, 9, 31, 2, 2, 3, 20, 19, 13, 14)	3.055 hour Interval 1.78 to 7.57	3.300 hour Interval 1.45 to 8.94	3.390 hour Interval 0.964 to 9.28	NA hour Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	NA hour Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	3.310 hour Interval 2.47 to 3.37	3.755 hour Interval 1.32 to 7.59	3.300 hour Interval 2.54 to 27.9	4.070 hour Interval 2.14 to 9.02	3.120 hour Interval 1.32 to 6.03	—	—	—	—	—
Apparent Terminal Half-Life (t1/2) of SAR245409 Day 15 (n=6, 8, 22, 1, 1, 2, 10, 15, 8, 10)	3.700 hour Interval 2.07 to 5.6	4.570 hour Interval 1.81 to 6.49	4.560 hour Interval 2.37 to 35.2	NA hour Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	NA hour Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	NA hour Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	2.840 hour Interval 1.48 to 5.63	4.050 hour Interval 2.74 to 7.87	6.170 hour Interval 3.43 to 11.8	3.065 hour Interval 1.79 to 5.37	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.

The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the dose with area under the plasma concentration time curve from time zero to infinity (AUC 0-inf)=Dose/AUC 0-inf.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=11 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=36 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=2 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=24 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=18 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Total Body Clearance (CL/f) of SAR245409 Day 1 (n=5, 9, 31, 2, 1, 3, 20, 17, 12, 12)	41.80 litre per hour Interval 10.62 to 164.5	42.93 litre per hour Interval 23.89 to 77.16	46.54 litre per hour Interval 34.42 to 62.94	NA litre per hour Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	NA litre per hour Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	151.4 litre per hour Interval 69.37 to 330.4	35.43 litre per hour Interval 25.26 to 49.69	48.40 litre per hour Interval 34.12 to 68.64	55.51 litre per hour Interval 25.52 to 120.7	61.29 litre per hour Interval 40.26 to 93.3	—	—	—	—	—
Total Body Clearance (CL/f) of SAR245409 Day 15 (n=6, 8, 25, 1, 1, 3, 17, 17, 10, 13)	33.78 litre per hour Interval 15.16 to 75.26	42.81 litre per hour Interval 22.39 to 81.85	51.38 litre per hour Interval 34.68 to 76.13	NA litre per hour Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	NA litre per hour Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	92.90 litre per hour Interval 9.667 to 892.8	29.28 litre per hour Interval 20.78 to 41.26	48.69 litre per hour Interval 31.25 to 75.88	51.24 litre per hour Interval 20.38 to 128.8	65.16 litre per hour Interval 38.64 to 109.9	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=11 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=36 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=2 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=26 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=24 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=18 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Apparent Volume of Distribution of Total SAR245409 During the Terminal Phase Following Oral Administration (Vz/f) Day 1 (n=5, 9, 31, 2, 1, 3, 20, 17, 12, 12)	174.8 litre Interval 71.24 to 429.0	223.4 litre Interval 116.2 to 429.6	238.5 litre Interval 179.0 to 317.8	NA litre Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	NA litre Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	658.0 litre Interval 211.9 to 2044.0	175.2 litre Interval 123.9 to 247.9	251.4 litre Interval 158.4 to 398.9	353.6 litre Interval 177.1 to 705.8	270.3 litre Interval 175.6 to 416.0	—	—	—	—	—
Apparent Volume of Distribution of Total SAR245409 During the Terminal Phase Following Oral Administration (Vz/f) Day 15 (n=6, 8, 25, 1, 1, 2, 17, 17, 10, 13 )	165.7 litre Interval 99.48 to 276.1	257.2 litre Interval 156.7 to 422.1	355.9 litre Interval 212.5 to 596.2	NA litre Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	NA litre Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	NA litre Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	132.8 litre Interval 96.16 to 183.4	247.1 litre Interval 149.4 to 410.7	475.9 litre Interval 128.0 to 1769.0	293.4 litre Interval 141.6 to 607.7	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set. Here "N" signifies number of participant analyzed for this outcome measure and "n" signifies the number of subjects evaluable at the specific time points.

Accumulation ratio (Racc) for AUCtau, calculated as Day 15 dosing interval AUCtau divided by Day 1 dosing interval AUCtau.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=8 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=25 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=15 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=17 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=10 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=13 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Accumulation Ratio (Racc) for AUCtau of SAR245409: Day 15	1.189 ratio Interval 0.6118 to 2.311	1.004 ratio Interval 0.4637 to 2.175	0.9450 ratio Interval 0.6749 to 1.323	NA ratio Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	NA ratio Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	1.800 ratio Interval 0.1724 to 18.79	1.256 ratio Interval 0.9407 to 1.676	0.9887 ratio Interval 0.7202 to 1.357	1.187 ratio Interval 0.7614 to 1.85	1.022 ratio Interval 0.6346 to 1.645	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts

Population: The PK analysis set. Here "N" signifies number of participant analyzed for this outcome measure and "n" signifies the number of subjects evaluable at the specific time points.

Accumulation ratio (Racc) for Cmax, calculated as Day 15 Cmax divided by Day 1 Cmax.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=6 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=8 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=25 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=17 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=17 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=10 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=13 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Accumulation Ratio (Racc) for Cmax of SAR245409: Day 15	1.041 Ratio Interval 0.6293 to 1.722	0.8133 Ratio Interval 0.3484 to 1.898	0.8962 Ratio Interval 0.6151 to 1.306	NA Ratio Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	NA Ratio Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.	1.336 Ratio Interval 0.03347 to 53.32	1.070 Ratio Interval 0.8319 to 1.375	0.8950 Ratio Interval 0.6951 to 1.152	0.9611 Ratio Interval 0.6441 to 1.434	0.9942 Ratio Interval 0.5447 to 1.815	—	—	—	—	—

SECONDARY outcome

Timeframe: DDI Evaluation: Day 1 and 3 (predose, 2, 4, 8 and 24 hours (hr) postdose); Day 2 and 4 (24 hr postdose); Cycle 1 Day 1 (C1D1) and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose)

Population: The Biomarker Analysis Set for pharmacodynamics (PD) marker analysis in PBMC included all subjects who received at least the first dose of both drugs and had provided at least one pre-dose sample and one post-dose sample. Here "n" signifies the number of subjects evaluable at the specific time points.

pS6 Concentrations in PBMCs was measured during DDI Evaluation period and Cycle 1 for DE cohorts. DDI evaluation period is a 4-day period that was performed within 1 week prior to Day 1 Cycle 1. In DDI evaluation period, On Day 1, SAR245409 was be administered alone, and on Day 3, Pimasertib was administered alone. No data were planned to be collected for "Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily", "Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily", "Pimasertib (MSC1936369) 30mg and SAR245409 70mg Once Daily" and "Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily" reporting arms.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) C1D1: Pre dose (n= 1,1,1,1,1,1,1)	51.32 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	83.52 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	96.98 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	47.09 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	50.17 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	4.18 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	36.03 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) DDI Day 1: Pre-dose (n= 1, 0, 0, 0, 0, 0, 1)	61.02 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	33.78 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) DDI Day 1: 2hr post-dose (n= 1,0,0,0,0,0,1)	36.15 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	29.84 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) DDI Day 1: 4hr post-dose (n= 1,0,0,0,0,0,1)	89.14 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	30.28 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) DDI Day 1: 8 hr post-dose(n= 1, 0, 0, 0, 0, 0, 1)	54.54 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	44.88 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) DDI Day 1: 24hr post-dose (n= 1,0,0,0,0,0,0)	88.80 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) DDI Day 2: 24hr post-dose (n= 0,0,0,0,0,0,1)	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	28.86 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) DDI Day 3: Pre-dose (n= 1, 0, 0, 0, 0, 0, 1)	57.51 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	14.90 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) DDI Day 3: 2hr post-dose (n= 1,0,0,0,0,0,1)	55.93 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	34.06 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) DDI Day 3: 4hr post-dose (n= 1,0,0,0,0,0,1)	36.76 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	1.03 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) DDI: Day 3: 8 hr post-dose(n= 1, 0, 0, 0, 0, 0, 1)	1.08 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	40.40 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) DDI:Day 3: 24hr post-dose (n= 1,0,0,0,0,0,0)	87.60 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) DDI Day 4: 24hr post-dose (n= 0,0,0,0,0,0,1)	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	1.04 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) C1D1: 2hr postdose (n= 1,1,1,1,1,1,1)	31.08 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	24.48 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	56.41 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	23.89 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	5.72 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	0.92 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.04 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) C1D1: 4hr postdose (n= 1,1,1,1,1,1,1)	25.71 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	46.95 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	50.11 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	29.85 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	18.21 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	0.72 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	0.94 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) C1D1: 8hr postdose (n= 1,1,1,1,1,1,1)	3.02 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.28 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	84.57 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	19.75 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	6.21 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.18 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	0.96 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) C1D1: 24hr postdose(n= 1,1,1,1,0,0,0)	46.16 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	72.14 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	74.15 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	53.47 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) C1D2: 24hr postdose (n= 0,0,0,0,1,1,1)	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	24.66 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.61 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.00 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) C1D15: pre-dose (n= 1,1,1,1,1,0,1)	43.48 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	81.29 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	67.69 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.20 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	33.43 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	0.98 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) C1D15: 2hr postdose (n= 1,1,1,1,1,0,1)	26.41 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	43.70 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	48.23 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	15.02 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	21.11 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	1.06 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) C1D15: 4hr postdose (n= 1,1,1,1,1,0,1)	41.34 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	53.37 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	92.67 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	0.96 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	19.68 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	1.03 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) C1D15: 8hr postdose (n= 1,1,1,1,1,0,1)	0.53 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	45.97 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	77.62 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	36.06 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	30.08 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	0.88 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) C1D15: 24hr postdose (n= 1,1,1,1,0,0,0)	69.93 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	0.76 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	114.39 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	70.46 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) C1D16: 24hr postdose (n= 0,0,0,0,1,0,1)	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	24.36 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	0.98 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) C1D19: pre-dose (n= 1,1,1,1,1,0,1)	68.48 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	90.02 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	125.77 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	82.06 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	30.58 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	49.62 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs) C1D19: 2hr postdose (n= 1,0,0,0,0,0,0)	4.34 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: DDI Evaluation: Day 1 and 3 (predose, 2, 4, 8 and 24 hours (hr) postdose); Day 2 and 4 (24 hr postdose); C1D1 and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose)

Population: Biomarker Analysis Set for pharmacodynamics marker analysis in PBMC included all subjects who received at least first dose of both drugs and had provided at least one pre-dose sample and one post-dose sample. Here "N" signifies number of subject analysed for this outcome measure" and "n" signifies number of subject analysed at specific time point.

pERK Concentrations in PBMCs was measured during DDI Evaluation period and Cycle 1 for DE cohorts. DDI evaluation period is a 4-day period that was performed within 1 week prior to Day 1 Cycle 1. In DDI evaluation period, On Day 1, SAR245409 was be administered alone, and on Day 3, Pimasertib was administered alone. No data were planned to be collected for "Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily", "Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily", "Pimasertib (MSC1936369) 30mg and SAR245409 70mg Once Daily" and "Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily" reporting arms.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
pERK Concentrations in PBMCs C1D1: 2hr postdose(n= 1,1,1,1,1,1,1)	2.37 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.33 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	2.78 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.54 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.40 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	0.95 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.04 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs DDI Day 1: Predose (n= 1, 0, 0, 0, 0, 0, 1)	6.77 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	10.55 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs DDI Day 1: 2 hr post-dose (n=1,0,0,0,0.0,1)	8.74 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	10.17 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs DDI Day 1: 4 hr post-dose ((n=1,0,0,0,0,0,1)	6.10 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	6.50 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs DDI Day 1: 8 hr post-dose(n= 1, 0, 0, 0, 0, 0, 1)	7.42 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	9.36 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs DDI Day 1: 24 hr post-dose (n=1,0,0,0,0,0,0)	10.84 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs DDI Day 2: 24 hr post-dose ((n= 0,0,0,0,0,0,1)	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	8.32 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs DDI Day 3: Pre-dose (n= 1, 0, 0, 0, 0, 0, 1)	9.46 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	8.94 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs DDI Day 3: 2 hr post-dose (n=1,0,0,0,0,0,1)	3.12 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	15.82 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs DDI Day 3: 4 hr post-dose (n-1,0,0,0,0,0,1)	6.74 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	0.68 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs DDI Day 3: 8 hr post-dose(n= 1, 0, 0, 0, 0, 0, 1)	0.81 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	15.68 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs DDI Day 3: 24 hr post-dose (n=1,0,0,0,0,0,0)	6.18 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs DDI Day 4: 24 hr post-dose (n=0,0,0,0,0,0,1)	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	1.06 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs C1D1: Pre dose (n=1,1,1,1,1,1,1)	5.56 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	3.45 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	6.96 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	3.25 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	3.35 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.97 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	7.42 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs C1D1: 4hr postdose(n= 1,1,1,1,1,1,1)	2.85 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.37 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	2.91 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.24 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.96 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.11 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.01 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs C1D1: 8hr postdose(n= 1,1,1,1,1,1,1)	0.67 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	0.94 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	3.40 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.96 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.27 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.12 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	0.82 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs C1D1: 24hr postdose(n= 1,1,1,1,0,0,0)	6.23 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	2.15 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	4.59 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	6.26 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs C1D2: 24hr postdose(n= 0,0,0,0,1,1,1)	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	3.45 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.26 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.05 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs C1D15: pre-dose(n= 1,1,1,1,1,0,1)	3.79 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	2.26 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	5.29 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.41 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.93 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	2.03 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs C1D15: 2hr postdose (n= 1,1,1,1,1,0,1)	2.16 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.34 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	2.83 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.60 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.55 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	0.94 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs C1D15: 4hr postdose (n= 1,1,1,1,1,0,1)	1.87 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.34 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	2.50 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	0.94 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.20 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	0.81 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs C1D15: 8hr postdose (n= 1,1,1,1,1,0,1)	1.92 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	2.08 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	3.38 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.10 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	1.74 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	0.99 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs C1D15: 24hr postdose (n= 1,1,1,1,0,0,0)	4.97 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	0.94 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	5.33 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	4.70 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs C1D16: 24hr postdose (n= 0,0,0,0,1,0,1)	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	2.36 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	0.99 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs C1D19: pre-dose (n= 1,1,1,1,1,0,1)	6.54 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	2.61 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	4.47 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	5.44 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	2.07 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	5.72 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	—	—	—	—	—	—	—	—
pERK Concentrations in PBMCs C1D19: 2hr postdose (n= 1,0,0,0,0,0,0)	1.60 fluorescence intensity Standard Deviation NA Data for standard deviation was not estimable as only one subject analyzed.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	NA fluorescence intensity Standard Deviation NA The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of randomisation every 6 weeks up to assessed up to 4 years

Population: The Efficacy Analysis Set (EEF) included all subjects who received at least 1 trial treatment dose (Pimasertib or SAR245409) and had radiographic baseline and at least one evaluable post baseline tumor assessment.

CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Outcome measures
Measure	Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily n=4 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily n=2 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily n=13 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily n=11 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily n=2 Participants Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily n=1 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily n=3 Participants Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily n=16 Participants Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily n=20 Participants Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily n=11 Participants Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily n=14 Participants Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Number of Subjects With Complete Tumor Response (CR), Partial Tumor Response (PR), or Stable Disease (SD) Stable disease	3 subjects	2 subjects	2 subjects	3 subjects	1 subjects	2 subjects	4 subjects	6 subjects	0 subjects	1 subjects	2 subjects	7 subjects	10 subjects	1 subjects	7 subjects
Number of Subjects With Complete Tumor Response (CR), Partial Tumor Response (PR), or Stable Disease (SD) Progressive disease	0 subjects	0 subjects	1 subjects	1 subjects	1 subjects	0 subjects	9 subjects	3 subjects	2 subjects	0 subjects	1 subjects	8 subjects	6 subjects	9 subjects	4 subjects
Number of Subjects With Complete Tumor Response (CR), Partial Tumor Response (PR), or Stable Disease (SD) Complete Response	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects	1 subjects
Number of Subjects With Complete Tumor Response (CR), Partial Tumor Response (PR), or Stable Disease (SD) Partial Response	0 subjects	1 subjects	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects	2 subjects	0 subjects	0 subjects	0 subjects	0 subjects	1 subjects	0 subjects	1 subjects
Number of Subjects With Complete Tumor Response (CR), Partial Tumor Response (PR), or Stable Disease (SD) Not Evaluable	0 subjects	0 subjects	0 subjects	0 subjects	2 subjects	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects	1 subjects	3 subjects	1 subjects	1 subjects

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MSC1936369B (Pimasertib) 15mg and SAR245409 30mg Once Daily n=3 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 15 milligram (mg) on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 30mg and SAR245409 30mg Once Daily n=3 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 15mg and SAR245409 50mg Once Daily n=3 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 15 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 30mg and SAR245409 50mg Once Daily n=4 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 60mg and SAR245409 50mg Once Daily n=4 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 30mg and SAR245409 70mg Once Daily n=3 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 60mg and SAR245409 70mg Once Daily n=19 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 90mg and SAR245409 70mg Once Daily n=14 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 60mg and SAR245409 90mg Once Daily n=3 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 60mg and SAR245409 30mg Twice Daily n=3 participants at risk MSC1936369B (Pimasertib) capsule administered twice at a dose of 60 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 and 15 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily n=4 participants at risk MSC1936369B (Pimasertib) capsule administered twice at a dose of 45 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 and 15 of each cycle (21 days) (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily n=26 participants at risk Participants with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily n=24 participants at risk Participants with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily n=18 participants at risk Participants with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily n=15 participants at risk Participants with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR HAEMORRHAGE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders LETHARGY	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders PRESYNCOPE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Psychiatric disorders CONFUSIONAL STATE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO CENTRAL NERVOUS SYSTEM	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders NAUSEA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders VOMITING	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ABDOMINAL PAIN LOWER	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ASCITES	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders DIARRHOEA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders DYSPHAGIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders PYREXIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.1% 4/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders DISEASE PROGRESSION	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.1% 4/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	12.5% 3/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders GAIT DISTURBANCE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Hepatobiliary disorders BILE DUCT OBSTRUCTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Hepatobiliary disorders HEPATIC FAILURE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Hepatobiliary disorders HYPERBILIRUBINAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations CELLULITIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations FUNGAL SKIN INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations INFLUENZA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations PELVIC ABSCESS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Injury, poisoning and procedural complications FALL	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations BLOOD CREATININE INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.8% 3/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders FAILURE TO THRIVE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders GROIN PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Psychiatric disorders HALLUCINATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Psychiatric disorders MENTAL STATUS CHANGES	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Renal and urinary disorders ACUTE KIDNEY INJURY	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Reproductive system and breast disorders VULVOVAGINAL PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders DERMATITIS ACNEIFORM	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders DERMATITIS EXFOLIATIVE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders RASH	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Vascular disorders DEEP VEIN THROMBOSIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Vascular disorders HYPERTENSION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Vascular disorders HYPOTENSION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders FATIGUE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Hepatobiliary disorders BILE DUCT STENOSIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations LUNG INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Vascular disorders SUPERIOR VENA CAVA SYNDROME	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Vascular disorders TEMPORAL ARTERITIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Cardiac disorders ATRIAL FLUTTER	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Blood and lymphatic system disorders ANAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Cardiac disorders BRADYCARDIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Cardiac disorders CARDIO-RESPIRATORY ARREST	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Cardiac disorders RIGHT VENTRICULAR DYSFUNCTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders INTESTINAL ISCHAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders LARGE INTESTINAL OBSTRUCTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders PANCREATITIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders STOMATITIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders GENERALISED OEDEMA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations PNEUMONIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations SEPSIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations ABDOMINAL INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations ESCHERICHIA INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations ESCHERICHIA SEPSIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations GASTROENTERITIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Injury, poisoning and procedural complications ACCIDENTAL OVERDOSE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Injury, poisoning and procedural complications OVERDOSE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations ELECTROCARDIOGRAM QT PROLONGED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders HEADACHE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders HEMIPARESIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders SPINAL CORD COMPRESSION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders SYNCOPE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Psychiatric disorders PSYCHOTIC DISORDER	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Vascular disorders EMBOLISM	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Immune system disorders ANAPHYLACTIC REACTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years

Other adverse events

Other adverse events
Measure	MSC1936369B (Pimasertib) 15mg and SAR245409 30mg Once Daily n=3 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 15 milligram (mg) on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 30mg and SAR245409 30mg Once Daily n=3 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 15mg and SAR245409 50mg Once Daily n=3 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 15 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 30mg and SAR245409 50mg Once Daily n=4 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 60mg and SAR245409 50mg Once Daily n=4 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 30mg and SAR245409 70mg Once Daily n=3 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 60mg and SAR245409 70mg Once Daily n=19 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 90mg and SAR245409 70mg Once Daily n=14 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 60mg and SAR245409 90mg Once Daily n=3 participants at risk MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 60mg and SAR245409 30mg Twice Daily n=3 participants at risk MSC1936369B (Pimasertib) capsule administered twice at a dose of 60 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 and 15 of each cycle (21 days) (DE cohort).	MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily n=4 participants at risk MSC1936369B (Pimasertib) capsule administered twice at a dose of 45 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 and 15 of each cycle (21 days) (DE cohort).	TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily n=26 participants at risk Participants with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).	NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily n=24 participants at risk Participants with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).	CRC: Pimasertib 60mg and SAR245409 70mg Once Daily n=18 participants at risk Participants with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).	MEL: Pimasertib 60mg and SAR245409 70mg Once Daily n=15 participants at risk Participants with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
General disorders TEMPERATURE INTOLERANCE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders PHOTOPSIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders RETINAL HAEMORRHAGE	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations TROPONIN INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations STAPHYLOCOCCAL INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Blood and lymphatic system disorders ANAEMIA	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	36.8% 7/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.4% 4/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	22.2% 4/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	19.2% 5/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Blood and lymphatic system disorders LEUKOCYTOSIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Blood and lymphatic system disorders ANAEMIA MACROCYTIC	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Cardiac disorders SINUS TACHYCARDIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Cardiac disorders PALPITATIONS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Cardiac disorders ATRIAL FLUTTER	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Cardiac disorders PERICARDIAL EFFUSION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Cardiac disorders TACHYCARDIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Cardiac disorders MYOCARDIAL INFARCTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Cardiac disorders SINUS BRADYCARDIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Ear and labyrinth disorders HEARING IMPAIRED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Ear and labyrinth disorders VERTIGO	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Endocrine disorders HYPOTHYROIDISM	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders SUBRETINAL FLUID	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.1% 4/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	35.7% 5/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders VISUAL ACUITY REDUCED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.8% 3/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	23.1% 6/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 6/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders VISUAL IMPAIRMENT	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.1% 4/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	23.1% 6/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders RETINAL DETACHMENT	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.1% 4/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 8/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	27.8% 5/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.0% 3/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders PERIORBITAL OEDEMA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.8% 3/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders VISION BLURRED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.8% 3/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	19.2% 5/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	16.7% 4/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	22.2% 4/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.0% 3/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders DETACHMENT OF RETINAL PIGMENT EPITHELIUM	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders MACULAR DETACHMENT	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	19.2% 5/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.0% 3/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders VITREOUS FLOATERS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders BLEPHARITIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders CATARACT	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders CHORIORETINOPATHY	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders DIPLOPIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders DRY EYE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders EYE OEDEMA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders EYE PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders GLAUCOMA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders MACULAR FIBROSIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders MACULAR HOLE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders RETINAL EXUDATES	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders XANTHOPSIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders Halo Vision	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders EYE COLOUR CHANGE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders EYE DISCHARGE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders EYE PRURITUS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders EYELID FUNCTION DISORDER	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders EYELIDS PRURITUS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders METAMORPHOPSIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Eye disorders RETINAL DEGENERATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders DIARRHOEA	100.0% 3/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	100.0% 4/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	52.6% 10/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	92.9% 13/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	100.0% 3/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	84.6% 22/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	79.2% 19/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	72.2% 13/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 10/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders NAUSEA	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	100.0% 3/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	36.8% 7/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	57.1% 8/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	100.0% 3/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	42.3% 11/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	62.5% 15/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	44.4% 8/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	46.7% 7/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders VOMITING	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	100.0% 3/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	42.1% 8/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	64.3% 9/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	75.0% 3/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	46.2% 12/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	45.8% 11/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	38.9% 7/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	53.3% 8/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders STOMATITIS	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.8% 3/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	42.3% 11/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.8% 5/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	27.8% 5/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders DRY MOUTH	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.8% 3/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	22.2% 4/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.1% 4/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders DYSPEPSIA	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.8% 3/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders CONSTIPATION	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	23.1% 6/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	12.5% 3/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.0% 3/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	23.1% 6/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.8% 5/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	16.7% 3/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders FLATULENCE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders GASTRITIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ABDOMINAL PAIN LOWER	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ASCITES	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders DIVERTICULUM	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders DYSPHAGIA	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders EPIGASTRIC DISCOMFORT	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ERUCTATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders HAEMORRHOIDS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders HIATUS HERNIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders LIP ULCERATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders MELAENA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders MOUTH ULCERATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders OESOPHAGITIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ORAL DYSAESTHESIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ORAL PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders REFLUX GASTRITIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders RETCHING	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders SENSITIVITY OF TEETH	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders TOOTHACHE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ENLARGED UVULA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders HYPOAESTHESIA ORAL	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ABDOMINAL DISTENSION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ANAL FISSURE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders GASTROINTESTINAL DISORDER	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders GASTROINTESTINAL INFLAMMATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders GLOSSITIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders LOWER GASTROINTESTINAL HAEMORRHAGE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders NEUROGENIC BOWEL	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ORAL DISCOMFORT	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Gastrointestinal disorders ORAL MUCOSAL ERYTHEMA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders FATIGUE	100.0% 3/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	75.0% 3/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	42.1% 8/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	64.3% 9/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	100.0% 3/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	100.0% 4/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	65.4% 17/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	58.3% 14/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 9/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	26.7% 4/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders OEDEMA PERIPHERAL	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	100.0% 3/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	36.8% 7/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 7/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	26.9% 7/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.8% 5/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	16.7% 3/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	26.7% 4/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders PYREXIA	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	26.3% 5/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	28.6% 4/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	26.9% 7/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	27.8% 5/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	26.7% 4/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders ASTHENIA	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.4% 4/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	16.7% 3/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.0% 3/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders CHILLS	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.8% 3/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.4% 4/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders FACE OEDEMA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders CHEST DISCOMFORT	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders CHEST PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders GAIT DISTURBANCE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders HERNIA PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders LOCAL SWELLING	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders MALAISE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders MUCOSAL INFLAMMATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders PERIPHERAL SWELLING	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders THROMBOSIS IN DEVICE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders FACIAL PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders GENERALISED OEDEMA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders PERFORMANCE STATUS DECREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders EARLY SATIETY	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders INFLAMMATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders MUCOSAL DRYNESS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
General disorders NODULE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Hepatobiliary disorders HYPERBILIRUBINAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Hepatobiliary disorders HEPATIC CIRRHOSIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Hepatobiliary disorders JAUNDICE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Hepatobiliary disorders HEPATITIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Hepatobiliary disorders PORTAL HYPERTENSION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Immune system disorders DRUG HYPERSENSITIVITY	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations URINARY TRACT INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	28.6% 4/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	16.7% 3/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations CELLULITIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations BACTERIAL INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations BODY TINEA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations BRONCHITIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations ENTEROCOCCAL BACTERAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations FUNGAL SKIN INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations LUNG INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations OESOPHAGEAL INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations ORAL FUNGAL INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations PNEUMONIA	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations RASH PUSTULAR	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations SINUSITIS BACTERIAL	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations SKIN INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations TINEA CRURIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations VULVOVAGINAL MYCOTIC INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations WOUND INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations ORAL CANDIDIASIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations DEVICE RELATED INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations ORAL HERPES	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations PARONYCHIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations BACTERIAL VAGINOSIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations CATHETER SITE INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations FURUNCLE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations HERPES VIRUS INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations LARYNGITIS VIRAL	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations LOCALISED INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations NAIL INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations NASOPHARYNGITIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations ORAL INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations PHARYNGITIS STREPTOCOCCAL	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations PNEUMONIA FUNGAL	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations VAGINAL INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Injury, poisoning and procedural complications FALL	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.8% 3/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Injury, poisoning and procedural complications ARTHROPOD BITE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Injury, poisoning and procedural complications CERVICAL VERTEBRAL FRACTURE	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Injury, poisoning and procedural complications INCISION SITE ERYTHEMA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Injury, poisoning and procedural complications TOOTH FRACTURE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	35.7% 5/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations BLOOD CREATININE INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations EJECTION FRACTION DECREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	12.5% 3/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations WEIGHT DECREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.8% 3/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	16.7% 3/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations LYMPHOCYTE COUNT DECREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	12.5% 3/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	16.7% 3/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations BLOOD CHOLESTEROL INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	23.1% 6/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.8% 5/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	22.2% 4/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	26.7% 4/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations BLOOD POTASSIUM DECREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations BLOOD UREA INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations BLOOD URINE PRESENT	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations HAEMOGLOBIN DECREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations INTRAOCULAR PRESSURE INCREASED	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Injury, poisoning and procedural complications PLATELET COUNT DECREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations URINE OUTPUT DECREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Injury, poisoning and procedural complications WEIGHT INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations BLOOD BILIRUBIN INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations HEART RATE INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations VITAMIN D DECREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations BLOOD PRESSURE INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations BLOOD TESTOSTERONE DECREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations BREATH SOUNDS ABNORMAL	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations ELECTROCARDIOGRAM QT PROLONGED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations LIPASE INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations PROTHROMBIN TIME PROLONGED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations TRANSAMINASES INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Investigations WHITE BLOOD CELL COUNT DECREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders DECREASED APPETITE	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	31.6% 6/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	35.7% 5/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	30.8% 8/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	29.2% 7/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	22.2% 4/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 5/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders DEHYDRATION	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	31.6% 6/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	34.6% 9/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders HYPOKALAEMIA	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.8% 3/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	23.1% 6/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	22.2% 4/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.8% 3/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	16.7% 3/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders HYPOMAGNESAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	28.6% 4/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	19.2% 5/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	22.2% 4/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders HYPOALBUMINAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	16.7% 3/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders HYPOCALCAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	22.2% 4/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders FLUID RETENTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders HYPERKALAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders FAILURE TO THRIVE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders FLUID OVERLOAD	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders HYPERTRIGLYCERIDAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders HYPERAMYLASAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders HYPOVOLAEMIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders MALNUTRITION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders ARTHRALGIA	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.8% 3/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	12.5% 3/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	26.7% 4/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	16.7% 4/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.0% 3/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	26.7% 4/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders ARTHROPATHY	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders FLANK PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders JOINT EFFUSION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	12.5% 3/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Metabolism and nutrition disorders MUSCULOSKELETAL CHEST PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders BONE PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders GROIN PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders MUSCLE TWITCHING	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL STIFFNESS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACROCHORDON	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIPOMA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR HAEMORRHAGE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) INFECTED NEOPLASM	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ONCOLOGIC COMPLICATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders DIZZINESS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.8% 3/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	26.9% 7/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	37.5% 9/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.0% 3/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders HEADACHE	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.4% 4/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 6/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.0% 3/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders DYSGEUSIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.0% 3/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders SOMNOLENCE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders COGNITIVE DISORDER	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders NEUROPATHY PERIPHERAL	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders PRESYNCOPE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders TREMOR	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders ATAXIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders BRAIN OEDEMA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders DEPRESSED LEVEL OF CONSCIOUSNESS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders DIZZINESS EXERTIONAL	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders HEMIANOPIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HYPOAESTHESIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders LETHARGY	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEMORY IMPAIRMENT	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PARAESTHESIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PERONEAL NERVE PALSY	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SPINAL CORD COMPRESSION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders SYNCOPE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders TRANSVERSE SINUS THROMBOSIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) VISUAL FIELD DEFECT	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders BALANCE DISORDER	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders PARAPLEGIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders BURNING SENSATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders DYSARTHRIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HYPOKINESIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders NEURALGIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders SCIATICA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Nervous system disorders SINUS HEADACHE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Psychiatric disorders ANXIETY	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.4% 4/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	12.5% 3/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.0% 3/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Psychiatric disorders INSOMNIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.4% 4/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Psychiatric disorders CONFUSIONAL STATE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Pregnancy, puerperium and perinatal conditions AGITATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Psychiatric disorders DEPRESSED MOOD	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Psychiatric disorders DEPRESSION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Psychiatric disorders DEPRESSIVE SYMPTOM	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Psychiatric disorders DELIRIUM	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Pregnancy, puerperium and perinatal conditions MAJOR DEPRESSION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Pregnancy, puerperium and perinatal conditions MENTAL STATUS CHANGES	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Renal and urinary disorders HAEMATURIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Renal and urinary disorders ACUTE KIDNEY INJURY	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Renal and urinary disorders DYSURIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Renal and urinary disorders NOCTURIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Renal and urinary disorders PROTEINURIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Renal and urinary disorders URINARY RETENTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Renal and urinary disorders CHROMATURIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Renal and urinary disorders MICTURITION URGENCY	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Renal and urinary disorders NEUROGENIC BLADDER	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Renal and urinary disorders POLYURIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Renal and urinary disorders RENAL FAILURE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Renal and urinary disorders URINARY INCONTINENCE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Renal and urinary disorders URINARY TRACT PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Reproductive system and breast disorders BREAST PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Reproductive system and breast disorders PELVIC PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Reproductive system and breast disorders VAGINAL DISCHARGE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Reproductive system and breast disorders BREAST MASS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.1% 4/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	35.7% 5/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.4% 4/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 6/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders COUGH	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	75.0% 3/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	16.7% 4/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	16.7% 4/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	14.3% 2/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	13.3% 2/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders PLEURITIC PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders DYSPHONIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders HICCUPS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders LUNG INFILTRATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.1% 2/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders SPUTUM INCREASED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders TACHYPNOEA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders WHEEZING	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	16.7% 4/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders HAEMOTHORAX	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders LARYNGEAL PAIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders PULMONARY CONGESTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders PULMONARY HAEMORRHAGE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders DERMATITIS ACNEIFORM	100.0% 3/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	47.4% 9/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	42.9% 6/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 13/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 8/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	22.2% 4/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	46.7% 7/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	75.0% 3/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	31.6% 6/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	35.7% 5/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	75.0% 3/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	23.1% 6/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 12/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	22.2% 4/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 5/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders PRURITUS	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	19.2% 5/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.8% 5/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 5/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders RASH	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.0% 3/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders DRY SKIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	21.4% 3/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	20.0% 3/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders PRURITUS GENERALISED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	50.0% 2/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders ALOPECIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	10.5% 2/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders ERYTHEMA	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	66.7% 2/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders SKIN DISORDER	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders ACNE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders ACTINIC KERATOSIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders DERMATITIS EXFOLIATIVE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders ECCHYMOSIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders GENERALISED ERYTHEMA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.3% 1/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders HAIR COLOUR CHANGES	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders HAIR GROWTH ABNORMAL	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders HYPERHIDROSIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders PAIN OF SKIN	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders PETECHIAE	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders RASH PAPULAR	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders RASH PRURITIC	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders SKIN LESION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders SKIN ULCER	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Respiratory, thoracic and mediastinal disorders SKIN BURNING SENSATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders DECUBITUS ULCER	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders RASH GENERALISED	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders RASH MACULAR	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders SKIN FISSURES	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders NAIL DISCOLOURATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders PHOTOSENSITIVITY REACTION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders SKIN DISCOLOURATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders SKIN EXFOLIATION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders URTICARIA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Skin and subcutaneous tissue disorders HYPERTENSION	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	15.8% 3/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	100.0% 3/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	25.0% 1/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	12.5% 3/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	5.6% 1/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 5/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Surgical and medical procedures DEEP VEIN THROMBOSIS	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.7% 2/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Surgical and medical procedures FLUSHING	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Surgical and medical procedures HOT FLUSH	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	7.1% 1/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Vascular disorders HYPOTENSION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	11.5% 3/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	8.3% 2/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Vascular disorders ORTHOSTATIC HYPOTENSION	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	33.3% 1/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Vascular disorders SUPERIOR VENA CAVA SYNDROME	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	4.2% 1/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Vascular disorders CAPILLARY LEAK SYNDROME	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Vascular disorders LYMPHOEDEMA	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	3.8% 1/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/15 • Baseline up to 30 Days after last dose; assessed up to 4 years
Vascular disorders PHLEBITIS SUPERFICIAL	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/19 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/14 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/3 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/4 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/26 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/24 • Baseline up to 30 Days after last dose; assessed up to 4 years	0.00% 0/18 • Baseline up to 30 Days after last dose; assessed up to 4 years	6.7% 1/15 • Baseline up to 30 Days after last dose; assessed up to 4 years

Additional Information

Merck KGaA Communication Center

Merck Serono, a business of Merck KGaA, Darmstadt, Germany

Phone: +496151725200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER