Open Label Treatment Extension Study With SAR245408 or SA... | NCT01587040

ID	Type	Description	Link
2011-006140-78	EudraCT Number
U1111-1124-1403	Other Identifier	UTN

Label	Type	Description	Intervention Names
SAR245408: Monotherapy	Experimental	Participants received SAR245408 400 milligrams (mg) once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).	Drug: SAR245408
SAR245408: Combination Regimen	Experimental	Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab).	Drug: SAR245408
SAR245409: Monotherapy	Experimental	Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days).	Drug: SAR245409
SAR245409: Combination Regimen	Experimental	Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).

Name	Type	Description	Arm Group Labels	Other Names
SAR245408	Drug	Pharmaceutical form: capsule or tablet Route of administration: oral	SAR245408: Combination Regimen SAR245408: Monotherapy

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. Serious adverse event (SAE): any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial/prolonged in-patient hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAEs: AEs that developed/worsened/became serious during on-treatment period (time from IMP until 30 days after last dose of any IMP). Any TEAE included participants with both SAE & non-SAEs. TEAE included participants with any treatment-emergent SAE (TESAE). TEAEs that led to death, dose reduction and/or delay, discontinuation & AEs related to treatment were reported. Grades (3=severe, 4=life-threatening/disabling) represents severity of AEs.	From Baseline up to 30 days after the last dose (maximum exposure: 1959 days)
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters	Hematological parameters assessed were anemia, neutropenia and thrombocytopenia. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.	From Baseline up to 30 days after the last dose (maximum exposure: 1959 days)
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters	Biochemical parameters assessed were hyperglycemia, aspartate aminotransferase (ASAT) increased, alanine aminotransferase (ALAT) increased, hyperbilirubinemia, hypocalcemia, creatinine increased. Parameters were assessed as per the NCI-CTCAE v 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.	From Baseline up to 30 days after the last dose (maximum exposure: 1959 days)

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number 840010		Birmingham	Alabama	35205	United States
Investigational Site Number 840009

ID	Title	Description
FG000	SAR245408: Monotherapy	Participants received SAR245408 400 milligrams (mg) once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 16, 2014	May 21, 2019

ID	Title	Description
BG000	SAR245408: Monotherapy	Participants received SAR245408 400 mg once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).
BG001	SAR245408: Combination Regimen	Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab).
BG002	SAR245409: Monotherapy	Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days).
BG003	SAR245409: Combination Regimen	Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00017 BG0013 BG00237 BG0034 BG00461

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDra 21.0	Systematic Assessment	EG0004 events3 affected17 at risk EG0011 events1 affected3 at risk EG0022 events2 affected37 at risk EG0030 events0 affected4 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Splenomegaly	Blood and lymphatic system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDra 21.0	Systematic Assessment	EG0003 events2 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Bradycardia	Cardiac disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Cardiac Arrest	Cardiac disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Cardiomegaly	Cardiac disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Coronary Artery Disease	Cardiac disorders	MedDra 21.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Pericardial Effusion	Cardiac disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Sinus Bradycardia	Cardiac disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Tachycardia	Cardiac disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Ventricular Extrasystoles	Cardiac disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Ventricular Tachycardia	Cardiac disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Cerumen Impaction	Ear and labyrinth disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Deafness Unilateral	Ear and labyrinth disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Ear Discomfort	Ear and labyrinth disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Hyperacusis	Ear and labyrinth disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Hypothyroidism	Endocrine disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Cataract	Eye disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Corneal Scar	Eye disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Dry Eye	Eye disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0020 events0 affected37 at risk EG003
Retinal Vein Occlusion	Eye disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Visual Impairment	Eye disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Vitreous Floaters	Eye disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Abdominal Pain Lower	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Abdominal Tenderness	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Abdominal Wall Haematoma	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Anal Incontinence	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Ascites	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Chapped Lips	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Constipation	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0004 events4 affected17 at risk EG0011 events1 affected3 at risk EG0027 events7 affected37 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0008 events7 affected17 at risk EG0012 events2 affected3 at risk EG00214 events14 affected37 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Faeces Discoloured	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Flatulence	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0004 events3 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Hypoaesthesia Oral	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Nausea	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0005 events5 affected17 at risk EG0012 events2 affected3 at risk EG00210 events10 affected37 at risk EG003
Pancreatic Failure	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Peptic Ulcer Haemorrhage	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Salivary Gland Enlargement	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Short-Bowel Syndrome	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Vomiting	Gastrointestinal disorders	MedDra 21.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0012 events2 affected3 at risk EG0027 events7 affected37 at risk EG003
Asthenia	General disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Catheter Site Discharge	General disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Chest Pain	General disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0021 events1 affected37 at risk EG003
Chills	General disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Face Oedema	General disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0020 events0 affected37 at risk EG003
Facial Pain	General disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Fatigue	General disorders	MedDra 21.0	Systematic Assessment	EG0009 events8 affected17 at risk EG0011 events1 affected3 at risk EG0028 events8 affected37 at risk EG003
Gait Disturbance	General disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
General Physical Health Deterioration	General disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Localised Oedema	General disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Malaise	General disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Mucosal Inflammation	General disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Non-Cardiac Chest Pain	General disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Oedema Peripheral	General disorders	MedDra 21.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0011 events1 affected3 at risk EG0024 events4 affected37 at risk EG003
Pain	General disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Performance Status Decreased	General disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Peripheral Swelling	General disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Pyrexia	General disorders	MedDra 21.0	Systematic Assessment	EG0004 events4 affected17 at risk EG0011 events1 affected3 at risk EG0026 events6 affected37 at risk EG003
Suprapubic Pain	General disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Contrast Media Allergy	Immune system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Drug Hypersensitivity	Immune system disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Hypersensitivity	Immune system disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Abscess Limb	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Bronchitis	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0025 events4 affected37 at risk EG003
Cellulitis	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Chronic Sinusitis	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Conjunctivitis	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Eye Infection	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Fungal Skin Infection	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Gastroenteritis	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Gastrointestinal Viral Infection	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Hepatitis C	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Herpes Zoster	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Hordeolum	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Influenza	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Lower Respiratory Tract Infection	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Nasopharyngitis	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Onychomycosis	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Oral Candidiasis	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Pneumonia	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Postoperative Wound Infection	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Respiratory Tract Infection	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Rhinitis	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Sepsis	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Sinusitis	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0025 events5 affected37 at risk EG003
Skin Infection	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Tooth Abscess	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Tooth Infection	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0010 events0 affected3 at risk EG0028 events8 affected37 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0011 events1 affected3 at risk EG0026 events6 affected37 at risk EG003
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Accidental Overdose	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Foreign Body In Eye	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Incision Site Pain	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Ligament Injury	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Limb Injury	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Muscle Strain	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Rib Fracture	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Skin Abrasion	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0020 events0 affected37 at risk EG003
Wound Dehiscence	Injury, poisoning and procedural complications	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0020 events0 affected37 at risk EG003
Activated Partial Thromboplastin Time Prolonged	Investigations	MedDra 21.0	Systematic Assessment	EG0003 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected3 at risk EG0025 events4 affected37 at risk EG003
Amylase Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0026 events6 affected37 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected3 at risk EG0023 events3 affected37 at risk EG003
Bilirubin Conjugated Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Blood Alkaline Phosphatase Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0022 events2 affected37 at risk EG003
Blood Bilirubin Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Blood Cholesterol Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Blood Creatinine Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Blood Lactate Dehydrogenase Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Blood Phosphorus Decreased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Blood Urea Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Body Temperature Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Breath Sounds Abnormal	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Breath Sounds Absent	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Cardiac Murmur	Investigations	MedDra 21.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Chest X-Ray Abnormal	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Electrocardiogram Qt Prolonged	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Heart Rate Irregular	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
International Normalised Ratio Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Lipase Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected3 at risk EG0028 events8 affected37 at risk EG003
Neutrophil Count Decreased	Investigations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Nuclear Magnetic Resonance Imaging Brain Abnormal	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Platelet Count Decreased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Procalcitonin Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Protein Urine Present	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Prothrombin Time Prolonged	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Red Blood Cell Count Decreased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Red Blood Cells Urine	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Urine Analysis Abnormal	Investigations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Urine Protein/Creatinine Ratio Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Vitamin B12 Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Vitamin D Decreased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Weight Decreased	Investigations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0024 events4 affected37 at risk EG003
Weight Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
White Blood Cell Count Decreased	Investigations	MedDra 21.0	Systematic Assessment	EG0002 events1 affected17 at risk EG0011 events1 affected3 at risk EG0021 events1 affected37 at risk EG003
White Blood Cell Count Increased	Investigations	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
White Blood Cells Urine	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
White Blood Cells Urine Positive	Investigations	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0020 events0 affected37 at risk EG003
Acidosis	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0011 events1 affected3 at risk EG0025 events5 affected37 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Diabetes Mellitus	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Gout	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected3 at risk EG0022 events2 affected37 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected3 at risk EG0021 events1 affected37 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected3 at risk EG0022 events2 affected37 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0003 events2 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Metabolic Acidosis	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Vitamin D Deficiency	Metabolism and nutrition disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0004 events4 affected17 at risk EG0011 events1 affected3 at risk EG0024 events4 affected37 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Flank Pain	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Groin Pain	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Muscle Twitching	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0022 events2 affected37 at risk EG003
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Pain In Jaw	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Pathological Fracture	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0020 events0 affected37 at risk EG003
Pubic Pain	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Scoliosis	Musculoskeletal and connective tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Squamous Cell Carcinoma Of Skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Tumour Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Amnesia	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Aphasia	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Ataxia	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Cognitive Disorder	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Dizziness	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Dizziness Postural	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Dysarthria	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Headache	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0026 events6 affected37 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Lethargy	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Memory Impairment	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Neuropathy Peripheral	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Paraesthesia	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Partial Seizures	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Peripheral Sensory Neuropathy	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected3 at risk EG0022 events2 affected37 at risk EG003
Sciatica	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Seizure	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Syncope	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Tremor	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Visual Field Defect	Nervous system disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Thrombosis In Device	Product Issues	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Anxiety	Psychiatric disorders	MedDra 21.0	Systematic Assessment	EG0004 events4 affected17 at risk EG0010 events0 affected3 at risk EG0024 events4 affected37 at risk EG003
Confusional State	Psychiatric disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Depression	Psychiatric disorders	MedDra 21.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Emotional Distress	Psychiatric disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Hallucination	Psychiatric disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Insomnia	Psychiatric disorders	MedDra 21.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Post-Traumatic Stress Disorder	Psychiatric disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Chronic Kidney Disease	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Dysuria	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0022 events2 affected37 at risk EG003
Glycosuria	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Haematuria	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Haemoglobinuria	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Micturition Urgency	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Nocturia	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Oliguria	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Proteinuria	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Renal Failure	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Urinary Hesitation	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Urinary Incontinence	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Urinary Retention	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Urinary Tract Pain	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0020 events0 affected37 at risk EG003
Urine Flow Decreased	Renal and urinary disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Prostatic Obstruction	Reproductive system and breast disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Testicular Swelling	Reproductive system and breast disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected3 at risk EG0028 events8 affected37 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0011 events1 affected3 at risk EG0023 events3 affected37 at risk EG003
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0022 events2 affected37 at risk EG003
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0003 events1 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Paranasal Sinus Discomfort	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0020 events0 affected37 at risk EG003
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0024 events4 affected37 at risk EG003
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Tonsillar Inflammation	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected3 at risk EG0022 events2 affected37 at risk EG003
Actinic Keratosis	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected3 at risk EG0021 events1 affected37 at risk EG003
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Dermatitis Acneiform	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Dry Skin	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0020 events0 affected37 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Ingrowing Nail	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events1 affected37 at risk EG003
Nail Pigmentation	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0020 events0 affected37 at risk EG003
Night Sweats	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0002 events1 affected17 at risk EG0010 events0 affected3 at risk EG0023 events3 affected37 at risk EG003
Onychoclasis	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Pain Of Skin	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Palmar-Plantar Erythrodysaesthesia Syndrome	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Photosensitivity Reaction	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Precancerous Skin Lesion	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0012 events2 affected3 at risk EG0022 events2 affected37 at risk EG003
Pruritus Generalised	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected3 at risk EG0022 events2 affected37 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0021 events1 affected37 at risk EG003
Rash Generalised	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Rash Macular	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Scab	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Seborrhoeic Dermatitis	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Skin Hyperpigmentation	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0020 events0 affected37 at risk EG003
Skin Lesion	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Skin Mass	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Swelling Face	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDra 21.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected3 at risk EG0020 events0 affected37 at risk EG003
Brachiocephalic Vein Thrombosis	Vascular disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected3 at risk EG0020 events0 affected37 at risk EG003
Deep Vein Thrombosis	Vascular disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0022 events2 affected37 at risk EG003
Flushing	Vascular disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Hot Flush	Vascular disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Hypertension	Vascular disorders	MedDra 21.0	Systematic Assessment	EG0005 events5 affected17 at risk EG0011 events1 affected3 at risk EG0028 events8 affected37 at risk EG003
Hypotension	Vascular disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Lymphoedema	Vascular disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003
Systolic Hypertension	Vascular disorders	MedDra 21.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected3 at risk EG0021 events1 affected37 at risk EG003

ID	Term
C581157	XL147
C576808	XL765

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SAR245408: Monotherapy	Participants received SAR245408 400 mg once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).	1	17	9	17	15	17
EG001	SAR245408: Combination Regimen	Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab).	0	3	1	3	3	3
EG002	SAR245409: Monotherapy	Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days).	3	37	10	37	34	37
EG003	SAR245409: Combination Regimen	Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).	0	4	0	4	3	4