Trial Outcomes & Findings for A Study of IMC-TR1 in Participants With Advanced Solid Tumors (NCT NCT01646203)
NCT ID: NCT01646203
Last Updated: 2019-01-18
Results Overview
A DLT was defined as an AE occurring during Cycle 1(first 6 weeks of treatment) that was considered at least possibly related to study drug, was considered dose-dependent, and fulfilled a criteria selected (using the National Cancer Institute Common Terminology Criteria for Adverse Events,version 4.0 \[NCI-CTCAE v 4.0\] \[NCI 2009\]):Grade(Gr)≥3 nonhematological toxicity,Gr4 thrombocytopenia lasting at least 5 days and/or complicated with bleeding,Gr≥3 febrile neutropenia(ntr),Gr4 ntr of \>5 days' duration,increase(incr)of at least 1 gr from a preexisting Gr1 valvular insufficiency or any new Gr≥2 valvular toxicity,left ventricular(vtr) ejection fraction decrease of 10% in absolute value or 16% in relative value,incr in right vtr systolic pressure dysfunction from mild to moderate(mod) or from mod to severe,incr in left atrial or ventricular chamber size of ≥2 cm and ≥1cm respectively,any other life-threatening toxicity,significant morphologic on cardiac echocardiogram,any major ocular.
COMPLETED
PHASE1
14 participants
First Dose Up to 6 Weeks
2019-01-18
Participant Flow
Participants that completed Cohort 1A, Cohort 1B or Cohort 2 are those who died, had progressive disease (PD) or off treatment \& censored due to study completion.
Participant milestones
| Measure |
1.25 mg/kg LY3022859
Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
|
12.5 mg LY3022859
Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
|
25 mg LY3022859
Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
5
|
7
|
|
Overall Study
Received at Least One Dose of Study Drug
|
2
|
5
|
7
|
|
Overall Study
COMPLETED
|
0
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
1.25 mg/kg LY3022859
Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
|
12.5 mg LY3022859
Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
|
25 mg LY3022859
Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Physician's Decision
|
0
|
1
|
0
|
Baseline Characteristics
A Study of IMC-TR1 in Participants With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
1.25 mg/kg LY3022859
n=2 Participants
Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
|
12.5 mg LY3022859
n=5 Participants
Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
|
25 mg LY3022859
n=7 Participants
Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 19.09 • n=5 Participants
|
62.2 years
STANDARD_DEVIATION 9.44 • n=7 Participants
|
55.0 years
STANDARD_DEVIATION 16.80 • n=5 Participants
|
59.1 years
STANDARD_DEVIATION 14.31 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
14 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: First Dose Up to 6 WeeksPopulation: All participants who received at least one dose of study drug.
A DLT was defined as an AE occurring during Cycle 1(first 6 weeks of treatment) that was considered at least possibly related to study drug, was considered dose-dependent, and fulfilled a criteria selected (using the National Cancer Institute Common Terminology Criteria for Adverse Events,version 4.0 \[NCI-CTCAE v 4.0\] \[NCI 2009\]):Grade(Gr)≥3 nonhematological toxicity,Gr4 thrombocytopenia lasting at least 5 days and/or complicated with bleeding,Gr≥3 febrile neutropenia(ntr),Gr4 ntr of \>5 days' duration,increase(incr)of at least 1 gr from a preexisting Gr1 valvular insufficiency or any new Gr≥2 valvular toxicity,left ventricular(vtr) ejection fraction decrease of 10% in absolute value or 16% in relative value,incr in right vtr systolic pressure dysfunction from mild to moderate(mod) or from mod to severe,incr in left atrial or ventricular chamber size of ≥2 cm and ≥1cm respectively,any other life-threatening toxicity,significant morphologic on cardiac echocardiogram,any major ocular.
Outcome measures
| Measure |
1.25 mg/kg LY3022859
n=2 Participants
Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
|
12.5 mg LY3022859
n=5 Participants
Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
|
25 mg LY3022859
n=7 Participants
Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.
|
|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
|
2 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: First Dose through Cycle 1 (6 Weeks)Population: All participants who received at least one dose of study drug and completed cycle 1 or discontinued treatment due to a DLT during the cycle 1.
The MTD was defined as the highest dose level at which ≤33% of participants experienced a DLT during Cycle 1.
Outcome measures
| Measure |
1.25 mg/kg LY3022859
n=3 Participants
Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
|
12.5 mg LY3022859
Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
|
25 mg LY3022859
Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of IMC-TR1
|
NA milligram (mg)
MTD was not reached.
|
—
|
—
|
SECONDARY outcome
Timeframe: First Dose through Cycle 1 (6 Weeks)Population: All participants who received at least one dose of study drug and completed cycle 1 or discontinued treatment due to a DLT during the cycle 1.
The MTD was defined as the highest dose level at which ≤33% of participants experienced a DLT during Cycle 1.
Outcome measures
| Measure |
1.25 mg/kg LY3022859
n=2 Participants
Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
|
12.5 mg LY3022859
Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
|
25 mg LY3022859
Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of IMC-TR1 (1.25 mg/kg LY3022859 ) for Participants Receiving a Weight-Based Dose
|
NA milligram/kilogram (mg/kg)
MTD was not reached.
|
—
|
—
|
SECONDARY outcome
Timeframe: First Dose through Cycle 1 (6 Weeks)Population: All participants who received at least one dose of study drug.
Outcome measures
| Measure |
1.25 mg/kg LY3022859
n=2 Participants
Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
|
12.5 mg LY3022859
n=5 Participants
Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
|
25 mg LY3022859
n=7 Participants
Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.
|
|---|---|---|---|
|
Number of Dose-Limiting Toxicities (DLTs)
|
2 DLTs
|
0 DLTs
|
2 DLTs
|
SECONDARY outcome
Timeframe: Cycle 1 - Day 1 and Day 29, Cycle 2 - Day 15, Cycle 3 and Each Consecutive Cycle - Day 1Population: Zero participants were analyzed. Immunogenicity data were not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First Dose to Measured Progressive Disease (Up To 21.3 Weeks)Population: All participants who received at least one dose of study drug.
ORR is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
Outcome measures
| Measure |
1.25 mg/kg LY3022859
n=2 Participants
Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
|
12.5 mg LY3022859
n=5 Participants
Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
|
25 mg LY3022859
n=7 Participants
Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.
|
|---|---|---|---|
|
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of IMC-TR1 as Monotherapy, Assessed Via Tumor Measurement by Response Evaluation Criteria in Solid Tumors, Version 1.1)
|
0 percentage of participants
Interval 0.0 to 84.2
|
0 percentage of participants
Interval 0.0 to 52.2
|
0 percentage of participants
Interval 0.0 to 41.0
|
SECONDARY outcome
Timeframe: Cycle (C) 1 Day (D) 1: 1, 2, 4, 8 hours (h); C1 D2: 24 h; C1 D3: 48 h; C1 D5: 96 h; C1 D8: 168 h; C1 D15: 336 h; C2 D15: 1, 2, 4, 8 h; C2 D16: 24 h; C2 D17: 48 h; C2 D19: 96 h; C2 D22: 168 h, C2 D29: 336 hPopulation: All participants who received at least one dose of study drug and had evaluable PK data. PK of LY3022859 was not characterized at the 1.25-mg/kg dose level because of infusion interruptions thus no data collected.
AUC (0-tlast) is area under the concentration versus time curve from the time zero to tlast. AUCτ is area under the concentration versus time curve during 1 dose interval (336 hours).
Outcome measures
| Measure |
1.25 mg/kg LY3022859
n=5 Participants
Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
|
12.5 mg LY3022859
n=5 Participants
Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
|
25 mg LY3022859
Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.
|
|---|---|---|---|
|
Pharmacokinetics (PK) - Area Under the Concentration-time Curve (AUC[0-tlast]) and AUCτ of IMC-TR1
Cycle 1 (AUC[0-tlast])
|
28.5 microgram*hour per milliliter(µg·hr/mL)
Geometric Coefficient of Variation 18
|
60.2 microgram*hour per milliliter(µg·hr/mL)
Geometric Coefficient of Variation 30
|
—
|
|
Pharmacokinetics (PK) - Area Under the Concentration-time Curve (AUC[0-tlast]) and AUCτ of IMC-TR1
Cycle 2 (AUCτ)
|
—
|
60.7 microgram*hour per milliliter(µg·hr/mL)
Geometric Coefficient of Variation 35
|
—
|
SECONDARY outcome
Timeframe: Cycle (C) 1 Day (D) 1: 1, 2, 4, 8 hours (h); C1 D2: 24 h; C1 D3: 48 h; C1 D5: 96 h; C1 D8: 168 h; C1 D15: 336 h; C2 D15: 1, 2, 4, 8 h; C2 D16: 24 h; C2 D17: 48 h; C2 D19: 96 h; C2 D22: 168 h, C2 D29: 336 hPopulation: All participants who received at least one dose of study drug and had evaluable PK data. PK of LY3022859 was not characterized at the 1.25 mg/kg dose level because of infusion interruptions thus no data collected.
Outcome measures
| Measure |
1.25 mg/kg LY3022859
n=5 Participants
Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
|
12.5 mg LY3022859
n=5 Participants
Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
|
25 mg LY3022859
Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.
|
|---|---|---|---|
|
Pharmacokinetics - Maximum Concentration (Cmax) of IMC-TR1
Cycle 1
|
4.34 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 9
|
5.10 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 21
|
—
|
|
Pharmacokinetics - Maximum Concentration (Cmax) of IMC-TR1
Cycle 2
|
3.52 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 9
|
5.01 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 28
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1: Prior to fourth infusion 0 hour (h)Population: All participants who received at least one dose of study drug and had evaluable PK data. PK of LY3022859 was not characterized at the 1.25 mg/kg dose level because of infusion interruptions thus no data collected.
Pharmacokinetics - Minimum concentration (Cmin) of IMC-TR1
Outcome measures
| Measure |
1.25 mg/kg LY3022859
n=2 Participants
Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
|
12.5 mg LY3022859
n=3 Participants
Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
|
25 mg LY3022859
Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.
|
|---|---|---|---|
|
Pharmacokinetics - Minimum Concentration (Cmin) of IMC-TR1
|
NA microgram/milliliter (µg/mL)
Geometric Coefficient of Variation NA
Concentrations were below the limit of quantification.
|
NA microgram/milliliter (µg/mL)
Geometric Coefficient of Variation NA
Concentrations were below the limit of quantification.
|
—
|
Adverse Events
1.25 mg/kg LY3022859
12.5 mg LY3022859
25 mg LY3022859
Serious adverse events
| Measure |
1.25 mg/kg LY3022859
n=2 participants at risk
Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
|
12.5 mg LY3022859
n=5 participants at risk
Cohorts 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
|
25 mg LY3022859
n=7 participants at risk
Cohorts 2: 25 mg IV once Q2W during 6-week treatment cycles.
|
|---|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2
|
0.00%
0/5
|
28.6%
2/7 • Number of events 2
|
|
Nervous system disorders
Syncope
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
Other adverse events
| Measure |
1.25 mg/kg LY3022859
n=2 participants at risk
Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
|
12.5 mg LY3022859
n=5 participants at risk
Cohorts 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
|
25 mg LY3022859
n=7 participants at risk
Cohorts 2: 25 mg IV once Q2W during 6-week treatment cycles.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2
|
20.0%
1/5 • Number of events 3
|
42.9%
3/7 • Number of events 7
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2
|
20.0%
1/5 • Number of events 2
|
0.00%
0/7
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1
|
20.0%
1/5 • Number of events 3
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2
|
20.0%
1/5 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Gingival inflammation
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2
|
40.0%
2/5 • Number of events 3
|
42.9%
3/7 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2
|
40.0%
2/5 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/2
|
40.0%
2/5 • Number of events 2
|
42.9%
3/7 • Number of events 3
|
|
General disorders
Malaise
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Oedema peripheral
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Otitis media
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
100.0%
2/2 • Number of events 2
|
0.00%
0/5
|
28.6%
2/7 • Number of events 3
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2
|
20.0%
1/5 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Amylase increased
|
0.00%
0/2
|
20.0%
1/5 • Number of events 3
|
0.00%
0/7
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
14.3%
1/7 • Number of events 2
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2
|
20.0%
1/5 • Number of events 2
|
0.00%
0/7
|
|
Investigations
Blood chloride decreased
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 2
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Occult blood positive
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Troponin increased
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2
|
0.00%
0/5
|
42.9%
3/7 • Number of events 4
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2
|
0.00%
0/5
|
28.6%
2/7 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2
|
0.00%
0/5
|
28.6%
2/7 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2
|
20.0%
1/5 • Number of events 2
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2
|
0.00%
0/5
|
28.6%
2/7 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
50.0%
1/2 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
|
Nervous system disorders
Headache
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2
|
0.00%
0/5
|
28.6%
2/7 • Number of events 2
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2
|
0.00%
0/5
|
28.6%
2/7 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60