Trial Outcomes & Findings for Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer (NCT NCT01737502)
NCT ID: NCT01737502
Last Updated: 2025-09-05
Results Overview
The number and severity of all adverse events (overall and by dose level) will be tabulated and summarized. A DLT is defined as an adverse event during the first cycle of, at least possibly related to study treatment, and one of the following: Grade 4 Neutropenia, Grade 4 Thrombocytopenia, ≥Grade 3 Anaphylaxis, ≥Grade 3 Proteinuria, ≥Grade 3 Hematuria, ≥Grade 3 Rash acneiform, ≥Grade 3 Diarrhea, ≥Grade 3 Mucositis oral
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
29 participants
Primary outcome timeframe
28 days
Results posted on
2025-09-05
Participant Flow
Participant milestones
| Measure |
Dose Level 0
Patients receive 3mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Auranofin: Given PO
\>
\> Sirolimus: Given PO
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Pharmacological Study: Correlative studies
|
Dose Level 1
Patients receive 6mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Auranofin: Given PO
\>
\> Sirolimus: Given PO
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Pharmacological Study: Correlative studies
|
|---|---|---|
|
Phase I
STARTED
|
3
|
3
|
|
Phase I
COMPLETED
|
0
|
0
|
|
Phase I
NOT COMPLETED
|
3
|
3
|
|
Phase II
STARTED
|
0
|
23
|
|
Phase II
COMPLETED
|
0
|
0
|
|
Phase II
NOT COMPLETED
|
0
|
23
|
Reasons for withdrawal
| Measure |
Dose Level 0
Patients receive 3mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Auranofin: Given PO
\>
\> Sirolimus: Given PO
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Pharmacological Study: Correlative studies
|
Dose Level 1
Patients receive 6mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Auranofin: Given PO
\>
\> Sirolimus: Given PO
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Pharmacological Study: Correlative studies
|
|---|---|---|
|
Phase I
Disease progression
|
2
|
3
|
|
Phase I
Complicating disease
|
1
|
0
|
|
Phase II
Adverse Event
|
0
|
3
|
|
Phase II
Disease progression
|
0
|
18
|
|
Phase II
Death
|
0
|
1
|
|
Phase II
Transition to hospice care
|
0
|
1
|
Baseline Characteristics
Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 0
n=3 Participants
Patients receive 3mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Auranofin: Given PO \> Sirolimus: Given PO \> Laboratory Biomarker Analysis: Correlative studies \> Pharmacological Study: Correlative studies
|
Dose Level 1
n=26 Participants
Patients receive 6mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Auranofin: Given PO \> Sirolimus: Given PO \> Laboratory Biomarker Analysis: Correlative studies \> Pharmacological Study: Correlative studies
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
62.38 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
61.52 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
26 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Histologic Type
Small cell lung cancer
|
0 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Histologic Type
Non-small cell lung cancer
|
2 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Histologic Type
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Only phase 1 patients were included in analysis
The number and severity of all adverse events (overall and by dose level) will be tabulated and summarized. A DLT is defined as an adverse event during the first cycle of, at least possibly related to study treatment, and one of the following: Grade 4 Neutropenia, Grade 4 Thrombocytopenia, ≥Grade 3 Anaphylaxis, ≥Grade 3 Proteinuria, ≥Grade 3 Hematuria, ≥Grade 3 Rash acneiform, ≥Grade 3 Diarrhea, ≥Grade 3 Mucositis oral
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
Patients receive 6mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Auranofin: Given PO \>
* Sirolimus: Given PO \>
* Laboratory Biomarker Analysis: Correlative studies \>
* Pharmacological Study: Correlative studies
|
Dose Level 0
n=3 Participants
Patients receive 3mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Auranofin: Given PO \>
* Sirolimus: Given PO \>
* Laboratory Biomarker Analysis: Correlative studies \>
* Pharmacological Study: Correlative studies
|
|---|---|---|
|
Number of Phase 1 Patients Experiencing a DLT
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Only phase 1 patients were included in analysis
Number and severity of all adverse events (overall and by dose level) will be tabulated and summarized.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
Patients receive 6mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Auranofin: Given PO \>
* Sirolimus: Given PO \>
* Laboratory Biomarker Analysis: Correlative studies \>
* Pharmacological Study: Correlative studies
|
Dose Level 0
n=3 Participants
Patients receive 3mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Auranofin: Given PO \>
* Sirolimus: Given PO \>
* Laboratory Biomarker Analysis: Correlative studies \>
* Pharmacological Study: Correlative studies
|
|---|---|---|
|
Number Phase 1 Patients Experiencing a Grade 3+ AE
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 4 monthsA patient is considered to be a 4-month progression-free survivor, or success, if the patient is 4 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. Additionally, an estimate and confidence interval for the 4-month progression-free survival rate incorporating censoring may be computed using the method of Kaplan-Meier.
Outcome measures
| Measure |
Dose Level 1
n=26 Participants
Patients receive 6mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Auranofin: Given PO \>
* Sirolimus: Given PO \>
* Laboratory Biomarker Analysis: Correlative studies \>
* Pharmacological Study: Correlative studies
|
Dose Level 0
n=3 Participants
Patients receive 3mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Auranofin: Given PO \>
* Sirolimus: Given PO \>
* Laboratory Biomarker Analysis: Correlative studies \>
* Pharmacological Study: Correlative studies
|
|---|---|---|
|
Progression-free Survival Rate
|
28.0 percentage of participants
Interval 12.1 to 49.4
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
SECONDARY outcome
Timeframe: up to 5 yearsOverall Survival (OS) is defined as the length of time from study enrollment until death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Dose Level 1
n=26 Participants
Patients receive 6mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Auranofin: Given PO \>
* Sirolimus: Given PO \>
* Laboratory Biomarker Analysis: Correlative studies \>
* Pharmacological Study: Correlative studies
|
Dose Level 0
n=3 Participants
Patients receive 3mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Auranofin: Given PO \>
* Sirolimus: Given PO \>
* Laboratory Biomarker Analysis: Correlative studies \>
* Pharmacological Study: Correlative studies
|
|---|---|---|
|
Overall Survival Time
|
8.6 months
Interval 7.5 to 11.7
|
4.9 months
Interval 3.6 to
Upper limit of the 95% Confidence Interval was not estimable due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: up to 5 yearsProgression-free survival is defined as the time from study enrollment until disease progression or death from any cause. The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Dose Level 1
n=26 Participants
Patients receive 6mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Auranofin: Given PO \>
* Sirolimus: Given PO \>
* Laboratory Biomarker Analysis: Correlative studies \>
* Pharmacological Study: Correlative studies
|
Dose Level 0
n=3 Participants
Patients receive 3mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Auranofin: Given PO \>
* Sirolimus: Given PO \>
* Laboratory Biomarker Analysis: Correlative studies \>
* Pharmacological Study: Correlative studies
|
|---|---|---|
|
Progression-free Survival Time
|
2.1 months
Interval 1.8 to 4.2
|
4.9 months
Interval 1.7 to
Upper limit of the 95% Confidence Interval was not estimable due to an insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Only patients with measurable disease were included in analysis
The overall response rate will be estimated in the subset of patients with measurable disease by the number of responses in evaluable patients with measurable disease divided by the total number of evaluable patients with measurable disease.
Outcome measures
| Measure |
Dose Level 1
n=21 Participants
Patients receive 6mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Auranofin: Given PO \>
* Sirolimus: Given PO \>
* Laboratory Biomarker Analysis: Correlative studies \>
* Pharmacological Study: Correlative studies
|
Dose Level 0
n=3 Participants
Patients receive 3mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Auranofin: Given PO \>
* Sirolimus: Given PO \>
* Laboratory Biomarker Analysis: Correlative studies \>
* Pharmacological Study: Correlative studies
|
|---|---|---|
|
Number of Patients Achieving a Complete Response (CR) or Partial Response (PR) Noted as the Objective Status
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Only patients that achieved a CR or PR for a known amount of time were included in analysis
Defined for all evaluable patients with measurable disease who have achieved a response as the date at which the patient's earliest best objective status is first noted to be a CR or PR to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Dose Level 1
n=2 Participants
Patients receive 6mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Auranofin: Given PO \>
* Sirolimus: Given PO \>
* Laboratory Biomarker Analysis: Correlative studies \>
* Pharmacological Study: Correlative studies
|
Dose Level 0
Patients receive 3mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Auranofin: Given PO \>
* Sirolimus: Given PO \>
* Laboratory Biomarker Analysis: Correlative studies \>
* Pharmacological Study: Correlative studies
|
|---|---|---|
|
Duration of Response
|
16.25 months
Interval 14.7 to 17.8
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 5 yearsWill be evaluated at baseline using the baseline tissue specimen and explored in relation to 4-month progression-free survival and subsequently in relation to other clinical outcomes such as tumor response and adverse event incidence using two-way tables and analyzed using Fisher's exact tests.
Outcome measures
Outcome data not reported
Adverse Events
Dose Level 0
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Level 1
Serious events: 8 serious events
Other events: 23 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Dose Level 0
n=3 participants at risk
Patients receive 3mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
* Auranofin: Given PO
* Sirolimus: Given PO
* Laboratory Biomarker Analysis: Correlative studies
* Pharmacological Study: Correlative studies
|
Dose Level 1
n=26 participants at risk
Patients receive 6mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
* Auranofin: Given PO
* Sirolimus: Given PO
* Laboratory Biomarker Analysis: Correlative studies
* Pharmacological Study: Correlative studies
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
General disorders
Chills
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
General disorders
Death NOS
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
General disorders
Fever
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Infections and infestations
Bladder infection
|
0.00%
0/3 • 5 years
|
7.7%
2/26 • Number of events 2 • 5 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • 5 years
|
7.7%
2/26 • Number of events 2 • 5 years
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/26 • 5 years
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/26 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Nervous system disorders
Stroke
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/26 • 5 years
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/26 • 5 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
Dose Level 0
n=3 participants at risk
Patients receive 3mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
* Auranofin: Given PO
* Sirolimus: Given PO
* Laboratory Biomarker Analysis: Correlative studies
* Pharmacological Study: Correlative studies
|
Dose Level 1
n=26 participants at risk
Patients receive 6mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
* Auranofin: Given PO
* Sirolimus: Given PO
* Laboratory Biomarker Analysis: Correlative studies
* Pharmacological Study: Correlative studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Number of events 3 • 5 years
|
69.2%
18/26 • Number of events 85 • 5 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • 5 years
|
65.4%
17/26 • Number of events 47 • 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • 5 years
|
7.7%
2/26 • Number of events 3 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • 5 years
|
46.2%
12/26 • Number of events 17 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 5 years
|
7.7%
2/26 • Number of events 3 • 5 years
|
|
General disorders
Edema limbs
|
0.00%
0/3 • 5 years
|
7.7%
2/26 • Number of events 2 • 5 years
|
|
General disorders
Fatigue
|
0.00%
0/3 • 5 years
|
7.7%
2/26 • Number of events 3 • 5 years
|
|
General disorders
Fever
|
0.00%
0/3 • 5 years
|
11.5%
3/26 • Number of events 3 • 5 years
|
|
Infections and infestations
Bladder infection
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 2 • 5 years
|
|
Infections and infestations
Bronchial infection
|
33.3%
1/3 • Number of events 1 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • Number of events 2 • 5 years
|
0.00%
0/26 • 5 years
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 2 • 5 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • 5 years
|
0.00%
0/26 • 5 years
|
|
Investigations
Cholesterol high
|
33.3%
1/3 • Number of events 1 • 5 years
|
50.0%
13/26 • Number of events 41 • 5 years
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Number of events 1 • 5 years
|
11.5%
3/26 • Number of events 21 • 5 years
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 2 • 5 years
|
19.2%
5/26 • Number of events 10 • 5 years
|
|
Investigations
Weight loss
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
66.7%
2/3 • Number of events 2 • 5 years
|
26.9%
7/26 • Number of events 14 • 5 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
66.7%
2/3 • Number of events 2 • 5 years
|
50.0%
13/26 • Number of events 53 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • 5 years
|
23.1%
6/26 • Number of events 15 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
3/3 • Number of events 3 • 5 years
|
15.4%
4/26 • Number of events 20 • 5 years
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • 5 years
|
15.4%
4/26 • Number of events 6 • 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • Number of events 1 • 5 years
|
19.2%
5/26 • Number of events 14 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 5 years
|
7.7%
2/26 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • 5 years
|
3.8%
1/26 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • 5 years
|
7.7%
2/26 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
66.7%
2/3 • Number of events 2 • 5 years
|
11.5%
3/26 • Number of events 5 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place