Trial Outcomes & Findings for Study of LY573636-sodium in Essential Thrombocythemia and Acute Myeloid Leukemia (NCT NCT00718159)
NCT ID: NCT00718159
Last Updated: 2019-01-10
Results Overview
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose at which no more than 1 of 6 participants experienced a dose-limiting toxicity (DLT) and level immediately below that which had ≥2 instances of DLT. A DLT is an adverse event (AE) observed during the first cycle of treatment that is believed to be related to LY573636 and fulfills any of the following: ET only , Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 hematologic toxicity for ≥3 days; For all, ≥Gr 3 nonhematological toxicity except for nausea/vomiting or diarrhea unless it fits the next criteria; ≥Gr 3 nausea, vomiting, or diarrhea that persists \>7 days despite maximal treatment; Gr 3 electrolyte disturbances that persist despite maximal measures; DLT can be declared if a participant experienced increasing toxicity during treatment. The primary outcome measure was not analyzed because the enrollment was stopped early before MTD was reached.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Predose up to 35 days postdose in Cycle 1
Results posted on
2019-01-10
Participant Flow
The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment. All participants who received at least 1 dose of study drug were considered to have completed the study.
Participant milestones
| Measure |
Cmax 250 μg/mL (AML)
Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 300 μg/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 350 μg/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 400 μg/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 5500 µg*hr/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms\*hour per milliliter (µg\*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 7000 µg*hr/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg\*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 5500 µg*hr/mL (ET)
Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg\*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
4
|
8
|
1
|
1
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
3
|
3
|
3
|
4
|
8
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
4
|
8
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cmax 250 μg/mL (AML)
Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 300 μg/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 350 μg/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 400 μg/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 5500 µg*hr/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms\*hour per milliliter (µg\*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 7000 µg*hr/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg\*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 5500 µg*hr/mL (ET)
Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg\*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
3
|
3
|
2
|
0
|
6
|
0
|
0
|
|
Overall Study
Death due to Adverse Event
|
0
|
0
|
0
|
2
|
2
|
0
|
0
|
|
Overall Study
Death due to Study Drug Toxicity
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
|
Overall Study
Investigator Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Study of LY573636-sodium in Essential Thrombocythemia and Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Cmax 250 μg/mL (AML)
n=3 Participants
Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 300 μg/mL (AML)
n=3 Participants
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 350 μg/mL (AML)
n=3 Participants
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 400 μg/mL (AML)
n=4 Participants
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 5500 µg*hr/mL (AML)
n=8 Participants
Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms\*hour per milliliter (µg\*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 7000 µg*hr/mL (AML)
n=1 Participants
Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg\*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 5500 µg*hr/mL (ET)
n=1 Participants
Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg\*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.22 years
n=5 Participants
|
52.48 years
n=7 Participants
|
66.62 years
n=5 Participants
|
55.46 years
n=4 Participants
|
58.57 years
n=21 Participants
|
81.19 years
n=10 Participants
|
65.09 years
n=115 Participants
|
56.86 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
14 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
9 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race · African
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
19 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race · East Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
23 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Predose up to 35 days postdose in Cycle 1Population: No participants were analyzed since the MTD was not reached.
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose at which no more than 1 of 6 participants experienced a dose-limiting toxicity (DLT) and level immediately below that which had ≥2 instances of DLT. A DLT is an adverse event (AE) observed during the first cycle of treatment that is believed to be related to LY573636 and fulfills any of the following: ET only , Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 hematologic toxicity for ≥3 days; For all, ≥Gr 3 nonhematological toxicity except for nausea/vomiting or diarrhea unless it fits the next criteria; ≥Gr 3 nausea, vomiting, or diarrhea that persists \>7 days despite maximal treatment; Gr 3 electrolyte disturbances that persist despite maximal measures; DLT can be declared if a participant experienced increasing toxicity during treatment. The primary outcome measure was not analyzed because the enrollment was stopped early before MTD was reached.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose,1h,2h,4h, 8d,14d,15d,21d,28d post dosePopulation: Participants who received the study drug and had pharmacokinetic (PK) data.
LY573636 has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636. PK sample is withdrawn at any time on days 8,14,15,21,28.
Outcome measures
| Measure |
Cmax 250 μg/mL (AML)
n=23 Participants
Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 300 μg/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 350 μg/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 400 μg/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 5500 µg*hr/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms\*hour per milliliter (µg\*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 7000 µg*hr/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg\*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 5500 µg*hr/mL (ET)
Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg\*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics Area Under the Curve(AUC) of LY573636 Above the Albumin-Corrected Threshold (AUCalb)
|
6911 micrograms*hour/milliliter (µg*hr/mL)
Geometric Coefficient of Variation 86.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to measured progressive disease up to 70 daysPopulation: All participants who received at least one dose of the study drug.
The International Working Group's revised recommendations were used to assess response in acute myeloid leukemia (AML): complete response (CR) is \<5% blasts in BM and with a cell count ≥200 cells in BM, and with peripheral blood platelets ≥100x10⁹/liter (L) and absolute neutrophils ≥1x10⁹/L; CR with incomplete blood count recovery is defined as CRi; partial response (PR) is ≥5% blasts in BM but with ≥50% reduction in blast count. Number of responders for AML = CR+PR+ CRi. Result of a European Leukemia Net consensus conference was used to assess response in essential thrombocythemia (ET). CR is platelets ≤400x10⁹/L in peripheral blood, no disease-related symptoms, normal spleen size and white blood cells ≤10x10⁹/L in peripheral blood; PR has platelets ≤600x10⁹/L in peripheral blood or decrease \> 50% from baseline but does not meet CR criteria. Number of responders for ET = CR+PR.
Outcome measures
| Measure |
Cmax 250 μg/mL (AML)
n=3 Participants
Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 300 μg/mL (AML)
n=3 Participants
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 350 μg/mL (AML)
n=3 Participants
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 400 μg/mL (AML)
n=4 Participants
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 5500 µg*hr/mL (AML)
n=8 Participants
Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms\*hour per milliliter (µg\*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 7000 µg*hr/mL (AML)
n=1 Participants
Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg\*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 5500 µg*hr/mL (ET)
n=1 Participants
Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg\*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Bone Marrow (BM) Response
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose,1h,2h,4h, 8d,14d,15d,21d,28d post dosePopulation: Participants who received the study drug and had pharmacokinetic (PK) data.
PK sample is withdrawn at any time on days 8,14,15,21,28.
Outcome measures
| Measure |
Cmax 250 μg/mL (AML)
n=23 Participants
Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 300 μg/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 350 μg/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 400 μg/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 5500 µg*hr/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms\*hour per milliliter (µg\*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 7000 µg*hr/mL (AML)
Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg\*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 5500 µg*hr/mL (ET)
Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg\*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Concentration Maximum (Cmax) of LY573636
|
317 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 21.0
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cmax 250 μg/mL (AML)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Cmax 300 μg/mL (AML)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cmax 350 μg/mL (AML)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cmax 400 μg/mL (AML)
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
AUCalb 5500 µg*hr/mL (AML and ET)
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
AUCalb 7000 µg*hr/mL (AML)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cmax 250 μg/mL (AML)
n=3 participants at risk
Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 300 μg/mL (AML)
n=3 participants at risk
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 350 μg/mL (AML)
n=3 participants at risk
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 400 μg/mL (AML)
n=4 participants at risk
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 5500 µg*hr/mL (AML and ET)
n=9 participants at risk
Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms\*hour per milliliter (µg\*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle.
Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg\*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle.
|
AUCalb 7000 µg*hr/mL (AML)
n=1 participants at risk
Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg\*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
3/9 • Number of events 3
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
0.00%
0/9
|
0.00%
0/1
|
|
Gastrointestinal disorders
Caecitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
22.2%
2/9 • Number of events 2
|
0.00%
0/1
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
22.2%
2/9 • Number of events 2
|
0.00%
0/1
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
100.0%
1/1 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Sepsis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
0.00%
0/9
|
0.00%
0/1
|
|
Infections and infestations
Septic shock
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
22.2%
2/9 • Number of events 2
|
0.00%
0/1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
Other adverse events
| Measure |
Cmax 250 μg/mL (AML)
n=3 participants at risk
Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 300 μg/mL (AML)
n=3 participants at risk
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 350 μg/mL (AML)
n=3 participants at risk
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
Cmax 400 μg/mL (AML)
n=4 participants at risk
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
|
AUCalb 5500 µg*hr/mL (AML and ET)
n=9 participants at risk
Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms\*hour per milliliter (µg\*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle.
Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg\*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle.
|
AUCalb 7000 µg*hr/mL (AML)
n=1 participants at risk
Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg\*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
50.0%
2/4 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
50.0%
2/4 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
100.0%
1/1 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
0.00%
0/9
|
0.00%
0/1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
100.0%
4/4 • Number of events 5
|
22.2%
2/9 • Number of events 3
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Gastrointestinal disorders
Haemorrhoids
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
100.0%
4/4 • Number of events 4
|
22.2%
2/9 • Number of events 2
|
0.00%
0/1
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Gastrointestinal disorders
Proctalgia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
75.0%
3/4 • Number of events 3
|
22.2%
2/9 • Number of events 2
|
0.00%
0/1
|
|
General disorders
Chest discomfort
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
General disorders
Chest pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
General disorders
Chills
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
General disorders
Fatigue
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
0.00%
0/1
|
|
General disorders
Inflammatory pain
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
3/9 • Number of events 3
|
0.00%
0/1
|
|
General disorders
Oedema
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
100.0%
1/1 • Number of events 1
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
General disorders
Therapeutic response unexpected
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
General disorders
Ulcer
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Anal infection
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Infections and infestations
Gastrointestinal infection
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Infections and infestations
Gingival infection
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Infections and infestations
Lobar pneumonia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Systemic candida
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
0.00%
0/9
|
0.00%
0/1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
22.2%
2/9 • Number of events 2
|
0.00%
0/1
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Blood creatinine
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
0.00%
0/1
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
100.0%
1/1 • Number of events 1
|
|
Investigations
Cardiac murmur
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Investigations
Fibrin d dimer increased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
100.0%
1/1 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Platelet count decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
100.0%
1/1 • Number of events 1
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
3/9 • Number of events 3
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
44.4%
4/9 • Number of events 4
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
44.4%
4/9 • Number of events 5
|
100.0%
1/1 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
22.2%
2/9 • Number of events 2
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
0.00%
0/9
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/9
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
50.0%
2/4 • Number of events 2
|
22.2%
2/9 • Number of events 2
|
0.00%
0/1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Psychiatric disorders
Depression
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
0.00%
0/9
|
0.00%
0/1
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
100.0%
1/1 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
0.00%
0/9
|
0.00%
0/1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
100.0%
1/1 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/2
|
0.00%
0/2
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
—
0/0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
44.4%
4/9 • Number of events 4
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
50.0%
2/4 • Number of events 2
|
44.4%
4/9 • Number of events 4
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
100.0%
1/1 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
|
Vascular disorders
Hypertension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
0.00%
0/1
|
|
Vascular disorders
Thrombophlebitis superficial
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60