Study of IDO Inhibitor and Temozolomide for Adult Patient... | NCT02052648

Label	Type	Description	Intervention Names
Phase 1b Cohort 1	Experimental	Phase 1B patients will receive Indoximod given in escalating doses. Initial dosing will be 600 mg BID by mouth with escalation planned to 1200 mg BID by mouth. The medication should be taken twice daily for 28 days each cycle. Temozolomide will also be given by mouth at 150 mg/m^2 x 5 days at all dosing levels of indoximod. Each cycle is 28 days. Patients will continue until they experience disease progression or toxicity.	Drug: Indoximod Drug: Temozolomide
Cohort 2a	Experimental	Bevacizumab naïve phase II patients who will receive indoximod with temozolomide. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2.	Drug: Indoximod Drug: Temozolomide
Cohort 2b	Experimental	Phase II patients who will receive indoximod with temozolomide and bevacizumab who have previously been treated with bevacizumab. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Bevacizumab will be dosed at 10mg/kg.	Drug: Indoximod Drug: Temozolomide Drug: Bevacizumab
Cohort 2c	Experimental	Phase II patients who will receive indoximod with temozolomide and stereotactic radiosurgery. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Single fraction SRS dose will be 16 or 20 Gy depending on target volume. The total 5-fraction SRT dose will be 27.5 Gy.

Name	Type	Description	Arm Group Labels	Other Names
Indoximod	Drug		Cohort 2a Cohort 2b Cohort 2c Phase 1b Cohort 1	1-methyl-D-tryptophan

Measure	Description	Time Frame
Frequency of Regimen-Limiting Toxicities (RLTs) in Phase 1 Subjects	Number of RLTs observed in each dose level.	3 months
Phase 2: Number of Phase 1 Participants With Efficacy Outcomes	Six-month progression-free survival.	6 months

Measure	Description	Time Frame
Overall Response Rate for Phase 2 Participants	Subjects with a complete response or partial response by RANO assessment. Overall Response Rate was only assessed in phase 2 subjects on this trial.	18 months
Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Facility	Status	City	State	ZIP	Country	Contacts
Eden Medical Center		Castro Valley	California	94546	United States
Cedars-Sinai Medical Center

ID	Title	Description
FG000	Phase 1 Dose Level 1	Phase 1 Cohort 1 patients will receive Indoximod given at 600 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m^2 x 5 days
FG001	Phase 1 Dose Level 2

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 27, 2015	Sep 20, 2023

ID	Title	Description
BG000	Phase 1 Dose Level 1	Phase 1 Cohort 1 patients will receive Indoximod given at 600 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m^2 x 5 days
BG001	Phase 1 Dose Level 2	Phase 1 Cohort 1 patients will receive Indoximod given at 1000 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m^2 x 5 days
BG002	Phase 1 Dose Level 3	Phase 1 Cohort 1 patients will receive Indoximod given at 1200 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m^2 x 5 days
BG003	Phase 2 Cohort 2a	Bevacizumab naïve phase II patients who will receive indoximod with temozolomide. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2.
BG004	Phase 2 Cohort 2b	Phase II patients who will receive indoximod with temozolomide and bevacizumab who have previously been treated with bevacizumab. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Bevacizumab will be dosed at 10mg/kg.
BG005	Phase 2 Cohort 2c	Phase II patients who will receive indoximod with temozolomide and stereotactic radiosurgery. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Single fraction SRS dose will be 16 or 20 Gy depending on target volume. The total 5-fraction SRT dose will be 27.5 Gy.
BG006	Total	Total of all reporting groups

Units	Counts
Participants	BG0003 BG0013 BG0026 BG00380 BG00428 BG00540 BG006160

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Headache	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected3 at risk EG0024 events4 affected6 at risk EG00322 events22 affected77 at risk EG0047 events7 affected28 at risk EG00519 events19 affected39 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected3 at risk EG0022 events2 affected6 at risk EG003
Aphasia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected6 at risk EG003
Ataxia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected6 at risk EG003
Hypoaesthesia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected6 at risk EG003
Hemiparesis	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Paraesthesia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected6 at risk EG003
Seizure	Nervous system disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected6 at risk EG003
Haemorrhage intracranial	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected6 at risk EG003
Memory impairment	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected6 at risk EG003
Restless legs syndrome	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected6 at risk EG003
Tremor	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected6 at risk EG003
Cognitive disorder	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Visual field defect	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Amnesia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Lethargy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Syncope	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Cerebrovascular accident	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Dysgeusia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Neurologic neglect syndrome	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Somnolence	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Aura	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Clonus	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Diplegia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Dyscalculia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Dyskinesia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Dysmetria	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Encephalopathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Facial paralysis	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Facial paresis	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hemianopia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hemianopia homonymous	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hypersomnia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Migraine	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Post herpetic neuralgia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Psychomotor skills impaired	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Transient ischaemic attack	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Upper motor neurone lesion	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Apraxia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Disturbance in attention	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Drooling	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Head discomfort	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hydrocephalus	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hyperreflexia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Ischaemic stroke	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Partial seizures	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Postictal paralysis	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Presyncope	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Radiculopathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Sensory loss	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Tardive dyskinesia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0002 affected3 at risk EG0013 affected3 at risk EG0024 affected6 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0002 affected3 at risk EG0011 affected3 at risk EG0020 affected6 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3 at risk EG0013 affected3 at risk EG0024 affected6 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected6 at risk EG003
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Dry mouth	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected6 at risk EG003
Flatulence	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected6 at risk EG003
Haemorrhoids	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Proctitis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Anal incontinence	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Colitis	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Haematochezia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Intestinal perforation	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Lip swelling	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Stomatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Toothache	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Dental caries	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Gastritis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Glossitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Large intestine perforation	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Oral dysaesthesia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Paraesthesia oral	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected6 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected6 at risk EG003
Asthenia	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected6 at risk EG003
Chills	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected6 at risk EG003
Pain	General disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected6 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected6 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected6 at risk EG003
Hyperchloraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected6 at risk EG003
Gait disturbance	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Oedema peripheral	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Chest discomfort	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Feeling cold	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Influenza like illness	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Malaise	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Swelling	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Chest pain	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Face oedema	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Mucosal inflammation	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Oedema	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Peripheral swelling	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Increased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hypophagia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected6 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected6 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected6 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected6 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected6 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected6 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Bone lesion	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Joint effusion	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Myopathy	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Posture abnormal	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected6 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected6 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected6 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Nasal dryness	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Pulmonary necrosis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Photophobia	Eye disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected6 at risk EG003
Diplopia	Eye disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected6 at risk EG003
Vision blurred	Eye disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Eye pain	Eye disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Photopsia	Eye disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Dry eye	Eye disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Erythema of eyelid	Eye disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Eye pruritus	Eye disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Ocular discomfort	Eye disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Visual impairment	Eye disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Insomnia	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected6 at risk EG003
Agitation	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected6 at risk EG003
Anxiety	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Personality change	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Abulia	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Affect lability	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Frustration tolerance	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Irritability	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Phonophobia	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Restlessness	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Suicidal ideation	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Bruxism	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Delirium	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hallucination,Visual	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Mania	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Psychotic disorder	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Confusional state	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected6 at risk EG003
Mood altered	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Sepsis	Infections and infestations	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected6 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Vaginal infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Angular cheilitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Candida infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Diverticulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Escherichia infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Herpes virus infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Herpes zoster	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Nail infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Cellulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Cystitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Fungal skin infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Otitis media	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Rash pustular	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Rhinitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Wound Infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Sinusitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected6 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected6 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Acne	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Precancerous skin lesion	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Blister	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hypotension	Vascular disorders	Systematic Assessment	EG0002 events2 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hypertension	Vascular disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Haematoma	Vascular disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Orthostatic hypotension	Vascular disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Embolism	Vascular disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Flushing	Vascular disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Traumatic haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Animal bite	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Laceration	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Post procedural persistent drain fluid	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Transfusion reaction	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Concussion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Eye contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Incision site pain s	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Procedural anxiety	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Skin abrasion	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Radiation necrosis	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Tongue injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Micturition urgency	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Nocturia	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Pollakiuria	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Urinary incontinence	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Proteinuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Urinary tract pain	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Chromaturia	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Cystitis noninfective	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Haematuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Incontinence	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Motion sickness	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Deafness	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Ear pain	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hypoacusis	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Inner ear disorder	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Middle ear effusion	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Tinnitus	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Angina pectoris	Cardiac disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Bradycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Sinus tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Bundle branch block right	Cardiac disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Sinus bradycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Ventricular arrhythmia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hypothyroidism	Endocrine disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Cushingoid	Endocrine disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hyperthyroidism	Endocrine disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Atrophic vulvovaginitis	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Breast pain	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Scrotal oedema	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Uterine polyp	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Hypersensitivity	Immune system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Acrochordon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Increased tendency to bruise	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Platelet count decreased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Lymphocyte count decreased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
White blood cell count decreased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Neutrophil count decreased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Alanine aminotransferase increase	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Weight increased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Blood alkaline phosphatase increased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Blood creatine phosphokinase increased blood	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Blood potassium decreased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
C-reactive protein increased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Haemoglobin decreased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Prothrombin time prolonged	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Weight decreased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
White blood cell count increased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Blood chloride decreased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003
Head lag abnormal	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected6 at risk EG003

ID	Term
D005909	Glioblastoma
D005910	Glioma
D018316	Gliosarcoma
D001932	Brain Neoplasms

ID	Term
D001254	Astrocytoma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009375	Neoplasms, Glandular and Epithelial
D009380	Neoplasms, Nerve Tissue
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
C525396	1-methyltryptophan
D000077204	Temozolomide
D000068258	Bevacizumab
D016634	Radiosurgery
D013097	Spermine Synthase

ID	Term
D003606	Dacarbazine
D014226	Triazenes
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D011878	Radiotherapy
D013812	Therapeutics
D013238	Stereotaxic Techniques
D019635	Neurosurgical Procedures
D013514	Surgical Procedures, Operative
D008919	Investigative Techniques
D019883	Alkyl and Aryl Transferases
D014166	Transferases
D004798	Enzymes
D045762	Enzymes and Coenzymes

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Phase 1 Dose Level 1	Phase 1 Cohort 1 patients will receive Indoximod given at 600 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m^2 x 5 days	3	3	2	3	3	3
EG001	Phase 1 Dose Level 2	Phase 1 Cohort 1 patients will receive Indoximod given at 1000 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m^2 x 5 days	3	3	1	3	3	3
EG002	Phase 1 Dose Level 3	Phase 1 Cohort 1 patients will receive Indoximod given at 1200 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m^2 x 5 days	6	6	1	6	6	6
EG003	Phase 2 Cohort 2a	Bevacizumab naïve phase II patients who will receive indoximod with temozolomide. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2.	67	77	21	77	77	77
EG004	Phase 2 Cohort 2b	Phase II patients who will receive indoximod with temozolomide and bevacizumab who have previously been treated with bevacizumab. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Bevacizumab will be dosed at 10mg/kg.	28	28	10	28	28	28
EG005	Phase 2 Cohort 2c	Phase II patients who will receive indoximod with temozolomide and stereotactic radiosurgery. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Single fraction SRS dose will be 16 or 20 Gy depending on target volume. The total 5-fraction SRT dose will be 27.5 Gy.	34	39	17	39	39	39