Study of IDO Inhibitor in Combination With Checkpoint Inh... | NCT02073123 | Trialant
NCT02073123
Sponsor
NewLink Genetics Corporation
Status
Completed
Last Update Posted
May 29, 2026Actual
Enrollment
131Actual
Phase
Phase 1Phase 2
Conditions
Metastatic Melanoma
Stage III Melanoma
Stage IV Melanoma
Interventions
Indoximod
Ipilimumab
Nivolumab
Pembrolizumab
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02073123
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
NLG2103
Secondary IDs
Not provided
Brief Title
Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma
Official Title
A Phase 1/2 Study of the Concomitant Administration of Indoximod Plus Immune Checkpoint Inhibitors for Adult Patients With Advanced or Metastatic Melanoma
Acronym
Not provided
Organization
Lumos PharmaINDUSTRY
Status Module
Record Verification Date
May 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 2014Actual
Primary Completion Date
Jan 17, 2018Actual
Completion Date
Jul 3, 2019Actual
First Submitted Date
Feb 25, 2014
First Submission Date that Met QC Criteria
Feb 25, 2014
First Posted Date
Feb 27, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 16, 2023
Results First Submitted that Met QC Criteria
May 4, 2026
Results First Posted Date
May 29, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 2, 2018
Certification/Extension First Submitted that Passed QC Review
Jul 2, 2018
Certification/Extension First Posted Date
Jul 5, 2018Actual
Last Update Submitted Date
May 4, 2026
Last Update Posted Date
May 29, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
NewLink Genetics CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
To evaluate the preliminary efficacy of the established dose of indoximod in combination with immune checkpoint inhibition as measured by the best overall response rate (ORR) (complete response (CR) + partial response (PR))across both standard of care agents administered sequentially in patients with unresectable stage III or stage IV melanoma
Detailed Description
The incidence of melanoma is increasing. Based upon data obtained between 2004 and 2006, the lifetime probability of developing melanoma in the United States is estimated to be 1 in 37 for men and 1 in 56 for women. In the United States, melanoma is the fifth leading cancer in men and the seventh in women. Locally confined, fully-resectable disease may be curable with current therapy; but Stage IV metastatic disease (or relapsed/recurrent disease) is highly refractory to therapy. Thus, experimental clinical trials provide an accepted treatment option for metastatic or relapsed/refractory melanoma.
The current study is designed as a prospective trial to evaluate the combination of indoximod and checkpoint inhibitors in adult patients with metastatic melanoma. Ipilimumab, pembrolizumab and nivolumab will be used at the recommended approved doses for this indication.
The current trial will be done in two phases: a Phase 1b dose escalation of indoximod in combination with ipilimumab, starting at half the recommended single-agent dose, to establish the recommended Phase 2 dose for the combination.
This will be followed by a three arm expansion study testing a fixed dose of indoximod (at the recommended Phase 2 dose) combined with standard-dose ipilimumab, pembrolizumab or nivolumab.
Treatment will be administered on an outpatient basis. No investigational or commercial cancer directed agents or therapies other than those described below may be administered.
Safety assessment will follow the guidelines provided in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version.4.03.
Patients will be followed both clinically and radiographically starting 12 weeks after initiation of treatment then every 8 weeks for tumor evaluation. Post-treatment scans will be compared to the baseline scan and responses will be assessed based using mWHO and immune related response criteria (irRC) described by Wolchok et al. (Wolchok et al., 2009).
Conditions Module
Conditions
Metastatic Melanoma
Stage III Melanoma
Stage IV Melanoma
Keywords
Metastatic melanoma
Stage III melanoma
Stage IV melanoma
unresectable
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
131Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Indoximod + Ipilimumab
Experimental
Indoximod will be administered at 1200mg BID by mouth.
Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
Indoximod and ipilimumab will be dosed concurrently. Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1). Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles. Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
Patients will continue until they experience disease progression or limiting toxicity.
Drug: Indoximod
Drug: Ipilimumab
Indoximod + Pembrolizumab
Experimental
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
Drug: Indoximod
Drug: Pembrolizumab
Indoximod + Nivolumab
Experimental
Indoximod will be administered at 1200mg BID by mouth.
Nivolumab administered intravenously at 240 mg every 2 weeks.
Drug: Indoximod
Drug: Nivolumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Indoximod
Drug
Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth
Dose escalation:
If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled
If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects
If > 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease
If >1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If >1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed
Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity
Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1 Regimen Limiting Toxicity of the Combination of Indoximod and Ipilimumab
Number subjects with at least one RLTs observed in each dose level.
6 weeks
Overall Response Rate
Phase 2 component: To evaluate the preliminary efficacy of the established dose of indoximod in combination with immune checkpoint inhibition as measured by the best overall response rate in patients with unresectable Stage III or Stage IV melanoma.
22 months
Secondary Outcomes
Measure
Description
Time Frame
Overall Survival
Phase 2 component: Overall survival (OS) and 95% confidence interval
24 months
Progression Free Survival
Phase 2 component: Time to progression with the combination indoximod with checkpoint inhibitor. Progression will be evaluated in this study using Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Unresectable Stage III or Stage IV melanoma.
Patients must have measurable disease, defined as lesions that can be accurately measure in in 2 perpendicular diameters with at least one diameter > 20mm and the other >10mm on conventional CT or MRI or 10mm x 10 mm by spiral CT.
No systemic treatment in the previous 28 days.
Age ≥18 years. Because no dosing or adverse event data are currently available on the use of ipilimumab or indoximod in patients <18 years of age, children are excluded from this study.
ECOG performance status ≤2 (Karnofsky ≥60% )
Patients with known brain metastases will only be eligible after their tumors have been treated with definitive resection and/or radiotherapy and they are neurologically stable for at least 1 month off steroids.
Exclusion Criteria:
Patients who have had molecular targeted therapy (including vemurafenib) or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Patients who have had prior therapy with immune checkpoint inhibition or or indoximod are excluded from the trial.
Any other cancer, unless the patient has been disease-free for ≥5 years
Patients with laboratory evidence of pancreatitis are excluded.
Patients with autoimmune disease
Chronic use of immune-suppressive drugs (ie, systemic corticosteroids used in the management of cancer or non-cancer related illnesses, eg, COPD).
Indoximod and ipilimumab will be dosed concurrently. Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1). Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles. Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
Periods
Title
Milestones
Reasons Not Completed
Phase 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_ICF
Yes
No
Yes
Study Protocol and Informed Consent Form
Feb 6, 2017
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Indoximod + Ipilimumab
Indoximod + Nivolumab
Indoximod + Pembrolizumab
1-methyl-D-tryptophan
D-1MT
Ipilimumab
Drug
Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
Indoximod + Ipilimumab
YERVOY
MDX-010
MDX-101
Nivolumab
Drug
Nivolumab administered intravenously at 240 mg every 2 weeks.
Indoximod + Nivolumab
Pembrolizumab
Drug
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
Indoximod + Pembrolizumab
24 months
Disease Control Rate
Phase 2 component: Disease control rate (CR, PR or SD)
22 months
Iowa City
Iowa
52242
United States
Mayo Clinic
Rochester
Minnesota
55905
United States
New Mexico Cancer Center Alliance
Albuquerque
New Mexico
87106
United States
Penn State Hershey Cancer Institue
Hershey
Pennsylvania
17033
United States
Huntsman Cancer Institute
Salt Lake City
Utah
84112
United States
FG001
Phase 1: Indoximod 1200mg + Ipilumumab
Indoximod and ipilimumab will be dosed concurrently. Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1). Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles. Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
FG002
Phase 2: Indoximod + Nivolumab
Indoximod will be administered at 1200mg BID by mouth.
Nivolumab administered intravenously at 240 mg every 2 weeks.
Indoximod: Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth
Dose escalation:
If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled
If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects
If > 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease
If >1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If >1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed
Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity
Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1
Nivolumab: Nivolumab administered intravenously at 240 mg every 2 weeks.
FG003
Phase 2: Indoximod + Ipilimumab
Indoximod and ipilimumab will be dosed concurrently. Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1). Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles. Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
Indoximod will be administered at 1200mg BID by mouth.
Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
FG004
Phase 2: Indoximod + Pembrolizumab
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
Indoximod: Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth
Dose escalation:
If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled
If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects
If > 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease
If >1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If >1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed
Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity
Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1
Pembrolizumab: Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
FG0003 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG0003 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Phase 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0034 subjects
FG004114 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0034 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1: Indoximod 600mg + Ipilumumab
Indoximod and ipilimumab will be dosed concurrently.
Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1).
Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles.
Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
BG001
Phase 1: Indoximod 1200mg + Ipilumumab
Indoximod and ipilimumab will be dosed concurrently.
Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1).
Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles.
Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
BG002
Phase 2: Indoximod + Ipilimumab
Indoximod and ipilimumab will be dosed concurrently.
Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1).
Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles.
Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
Indoximod will be administered at 1200mg BID by mouth.
Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
BG003
Phase 2: Indoximod + Nivolumab
Indoximod will be administered at 1200mg BID by mouth.
Nivolumab administered intravenously at 240 mg every 2 weeks.
Indoximod: Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth.
Dose escalation:
If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled
If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects
If > 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease
If >1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If >1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed
Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity.
Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1
Nivolumab: Nivolumab administered intravenously at 240 mg every 2 weeks.
BG004
Phase 2: Indoximod + Pembrolizumab
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
Indoximod: Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth.
Dose escalation:
If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled
If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects
If > 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease
If >1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If >1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed
Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity
Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1.
Pembrolizumab: Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0016
BG0024
BG0034
BG004114
BG005131
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00054.67± 13.43
BG00164.17± 12.51
BG00270.0± 9.80
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0016
BG002
Weight
Mean
Standard Deviation
Kilograms
Title
Denominators
Categories
Title
Measurements
BG00084.49± 11.53
BG00183.65± 15.76
BG002
Height
Mean
Standard Deviation
centimeters
Title
Denominators
Categories
Title
Measurements
BG000170.67± 10.06
BG001172.38± 6.34
BG002
BMI
Mean
Standard Deviation
kg/m2
Title
Denominators
Categories
Title
Measurements
BG00028.8± 5.75
BG00128.04± 4.11
BG002
BSA
Mean
Standard Deviation
m2
Title
Denominators
Categories
Title
Measurements
BG0001.99± 0.29
BG0012.0± 0.21
BG002
Eastern Cooperative Oncology Group (ECOG) Performance Status
0=Fully active, able to carry on all pre-disease performance without restriction
Restricted in physically strenuous activity but ambulatory and able to do light work or sedentary nature
Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
Dead
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG000.3± 0.58
BG001
American Joint Committee on Cancer (AJCC) staging
AJCC staging:
Stage III A: Thin tumors (<2 mm) that have spread to 1-3 lymph nodes. Stage III B: Can be a tumor of any thickness, with or without ulceration. Spread to 1-3 lymph nodes OR the presence of in-transit/satellite metastases without node involvement.
Stage III C: Advanced stage, 1+ lymph nodes or significant local spread. Often 4 or more lymph nodes, matted nodes, or in-transit/satellite metastases combined with node involvement.
Stage IV: distant metastasis to other places such as brain, lungs, liver, or gastrointestinal tract.
Number
participants
Title
Denominators
Categories
IIIA
Title
Measurements
BG0000
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase 1 Regimen Limiting Toxicity of the Combination of Indoximod and Ipilimumab
Number subjects with at least one RLTs observed in each dose level.
Posted
Count of Participants
Participants
6 weeks
ID
Title
Description
OG000
Phase 1: Dose Level 1
Indoximod and ipilimumab will be dosed concurrently.
Indoximod 600mg BID by mouth
Ipilimumab 3mg/kg Q3 weeks x 4 doses
OG001
Phase 1: Dose Level 2
Indoximod and ipilimumab will be dosed concurrently.
Indoximod 1200mg BID by mouth
Ipilimumab 3mg/kg Q3 weeks x 4 doses
Units
Counts
Participants
OG0003
OG0016
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
Primary
Overall Response Rate
Phase 2 component: To evaluate the preliminary efficacy of the established dose of indoximod in combination with immune checkpoint inhibition as measured by the best overall response rate in patients with unresectable Stage III or Stage IV melanoma.
Posted
Count of Participants
Participants
22 months
ID
Title
Description
OG000
Phase 2: Indoximod + Ipilimumab
Indoximod will be administered at 1200mg BID by mouth.
Ipilimumab: Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
OG001
Phase 2: Indoximod + Nivolumab
Indoximod will be administered at 1200mg BID by mouth.
Nivolumab administered intravenously at 240 mg every 2 weeks.
OG002
Phase 2: Indoximod + Pembrolizumab
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
Units
Counts
Participants
Secondary
Overall Survival
Phase 2 component: Overall survival (OS) and 95% confidence interval
It was pre-specified to assess this Outcome Measure for Phase 2 Arm/Groups only.
Posted
Median
95% Confidence Interval
weeks
24 months
ID
Title
Description
OG000
Phase 2: Indoximod + Ipilimumab
Indoximod will be administered at 1200mg BID by mouth.
Ipilimumab: Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
OG001
Phase 2: Indoximod + Nivolumab
Indoximod will be administered at 1200mg BID by mouth.
Nivolumab administered intravenously at 240 mg every 2 weeks.
OG002
Phase 2: Indoximod + Pembrolizumab
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
Units
Counts
Participants
Secondary
Progression Free Survival
Phase 2 component: Time to progression with the combination indoximod with checkpoint inhibitor. Progression will be evaluated in this study using Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).
It was pre-specified to assess this Outcome Measure for Phase 2 Arm/Groups only.
Posted
Median
95% Confidence Interval
Weeks
24 months
ID
Title
Description
OG000
Phase 2: Indoximod + Ipilimumab
Indoximod will be administered at 1200mg BID by mouth.
Ipilimumab: Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
OG001
Phase 2: Indoximod + Nivolumab
Indoximod will be administered at 1200mg BID by mouth.
Nivolumab administered intravenously at 240 mg every 2 weeks.
OG002
Phase 2: Indoximod + Pembrolizumab
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
Units
Secondary
Disease Control Rate
Phase 2 component: Disease control rate (CR, PR or SD)
It was pre-specified to assess this Outcome Measure for Phase 2 Arm/Groups only.
Posted
Count of Participants
Participants
22 months
ID
Title
Description
OG000
Phase 2: Indoximod + Ipilimumab
Indoximod will be administered at 1200mg BID by mouth.
Ipilimumab: Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
OG001
Phase 2: Indoximod + Nivolumab
Indoximod will be administered at 1200mg BID by mouth.
Nivolumab administered intravenously at 240 mg every 2 weeks.
OG002
Phase 2: Indoximod + Pembrolizumab
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
Units
Counts
Participants
Time Frame
Adverse events were captured from the first dose of study drug through study completion up to 24 months.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
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: Indoximod 600mg + Ipilumumab
Indoximod and ipilimumab will be dosed concurrently.
Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1).
Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles.
Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
0
3
0
3
3
3
EG001
Phase 1: Indoximod 1200mg + Ipilumumab
Indoximod and ipilimumab will be dosed concurrently.
Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1).
Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles.
Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
0
6
2
6
6
6
EG002
Phase 2: Indoximod + Ipilimumab
Indoximod and ipilimumab will be dosed concurrently.
Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1).
Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles.
Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
Indoximod will be administered at 1200mg BID by mouth.
Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
0
4
2
4
4
4
EG003
Phase 2: Indoximod + Nivolumab
Indoximod will be administered at 1200mg BID by mouth.
Nivolumab administered intravenously at 240 mg every 2 weeks.
Indoximod: Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth
Dose escalation:
If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled
If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects
If > 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease
If >1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If >1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed
Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity
Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1
Nivolumab: Nivolumab administered intravenously at 240 mg every 2 weeks.
0
4
3
4
4
4
EG004
Phase 2: Indoximod + Pembrolizumab
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
Indoximod: Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth
Dose escalation:
If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled
If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects
If > 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease
If >1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If >1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed
Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity
Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1
Pembrolizumab: Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
2
114
39
114
114
114
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Autoimmune haemolytic anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected4 at risk
EG0041 events1 affected114 at risk
Thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Atrial fibrillation
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Atrial flutter
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Colitis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Gastritis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Device related thrombosis
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Oedema peripheral
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pain
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pneumatosis
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Appendicitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Bacteraemia
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Enterovirus infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Influenza
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Urostomy complication
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Seizure
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Cerebrovascular accident
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Memory impairment
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Spinal cord compression
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected4 at risk
EG00414 events14 affected114 at risk
Thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Autoimmune haemolytic anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Sinus tachycardia
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Palpitations
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Tachycardia
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Atrial fibrillation
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Atrial flutter
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Cardiac failure
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Diastolic dysfunction
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Ventricular tachycardia
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Tinnitus
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Vertigo
Cardiac disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
External ear inflammation
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Inner ear inflammation
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypothyroidism
Endocrine disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Adrenal insufficiency
Endocrine disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hyperthyroidism
Endocrine disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypophysitis
Endocrine disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Vision blurred
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Lacrimation increased
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Dry eye
Eye disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Eye pain
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Eye irritation
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Eyelid function disorder
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Eyelid oedema
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Photophobia
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Cataract
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Conjunctival hyperaemia
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Conjunctival oedema
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Corneal bleeding
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Diplopia
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Glaucoma
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Keratitis
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Optic atrophy
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Retinal aneurysm
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Retinal haemorrhage
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Visual impairment
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Vitreous floaters
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0022 events2 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events4 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0023 events3 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Colitis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pancreatitis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Flatulence
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Gastritis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Haematochezia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Oral pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Toothache
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Enterocolitis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Eructation
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Lip blister
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Lip dry
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Lip swelling
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Oesophageal haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Oral disorder
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Regurgitation
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Sensitivity of teeth
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Small intestine ulcer
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0003 events3 affected3 at risk
EG0014 events4 affected6 at risk
EG0022 events2 affected4 at risk
EG003
Chills
General disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Oedema peripheral
General disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Influenza like illness
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Asthenia
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pain
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Chest pain
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 affected4 at risk
EG003
Gait disturbance
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Facial pain
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Mucosal inflammation
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Face oedema
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Thirst
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Chest discomfort
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Device related thrombosis
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Early satiety
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Hypothermia
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Injection site reaction
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Localised oedema
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Malaise
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Medical device site pain
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Oedema
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Peripheral swelling
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pneumatosis
General disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hepatitis
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Seasonal allergy
Immune system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Cytokine release syndrome
Immune system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypersensitivity
Immune system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Sinusitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Appendicitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Bronchitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Conjunctivitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Eye infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Folliculitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Gastroenteritis viral
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 affected4 at risk
EG003
Herpes zoster
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Influenza
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Rhinitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Tooth infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Bacteraemia
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Candida infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Cellulitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Cystitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Diverticulitis
Immune system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Fungal infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Lip infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Lung infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Lymph gland infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Mucosal infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Oral herpes
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Otitis media
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Skin candida
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Skin infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Tinea infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Contusion
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Laceration
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Urostomy complication
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Weight decreased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected4 at risk
EG003
Lipase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Blood creatinine increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Weight increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Amylase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Lymphocyte count decreased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Blood bilirubin increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Haemoglobin decreased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Neutrophil count decreased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
White blood cell count decreased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Bacterial test
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Blood alkaline phosphatase decreased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Blood chloride decreased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Blood cholesterol increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Blood creatine increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Blood creatine phosphokinase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Blood glucose increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
C-reactive protein increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Haemoglobin increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
International normalised ratio increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Platelet count decreased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Red blood cell sedimentation rate increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Troponin increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
White blood cell count increased
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
White blood cells urine positive
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Mobility decreased
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Soft tissue mass
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Brain neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Brain neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Brain oedema
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Dizziness
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Cognitive disorder
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Haemorrhage intracranial
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Depressed level of consciousness
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hemiparesis
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Seizure
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Spinal cord compression
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Syncope
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Confusional state
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Delirium
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Insomnia
Psychiatric disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Hydronephrosis
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Dysphonia
Investigations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0014 events4 affected6 at risk
EG0022 events2 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected4 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypertension
Vascular disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypotension
Vascular disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Enterovirus infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Acrochordon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Benign neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Benign lymph node neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Neoplasm skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Oral neoplasm benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)