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Trial Outcomes & Findings for Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies. (NCT NCT00162136)

NCT ID: NCT00162136

Last Updated: 2020-11-02

Results Overview

Dose limiting toxicities=any of the following events attributed to Ixabepilone occuring during the first cycle: grade 3/4 nausea, vomiting, or diarrhea despite medical intervention and/or prophylaxis; other Grade ≥3 nonhematological toxicity; any toxicity requiring study therapy discontinuation; delayed recovery from study therapy-related toxicity which delays scheduled re-treatment for \>14 days; Grade 4 neutropenia for ≥5 consecutive days; grade 3/4 neutropenia with sepsis or a fever ≥38.5 C; thrombocytopenia \<25,000 cells/mm3 or bleeding requiring a platelet transfusion.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

35 participants

Primary outcome timeframe

Measures taken at Cycle 01 (21-day cycle)

Results posted on

2020-11-02

Participant Flow

A total of 39 participants enrolled and 4 participants were never treated (2 reported serious adverse events \[SAEs\] prior to the first dose of study medication and were never treated; 1 had rapid decline in performance status and died prior to the first dose of study medication; no reason was given for the remaining participant).

Participant milestones

Participant milestones
Measure
Ixabepilone
Intravenous (IV) Infusion; 10, 20, 30, 35, 40 \& 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles
Overall Study
STARTED
35
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
35

Reasons for withdrawal

Reasons for withdrawal
Measure
Ixabepilone
Intravenous (IV) Infusion; 10, 20, 30, 35, 40 \& 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles
Overall Study
Adverse Event
1
Overall Study
Death
1
Overall Study
Disease Progression/Relapse
23
Overall Study
Investigator Request
5
Overall Study
Study Drug Toxicity
4
Overall Study
Withdrawal by Subject
1

Baseline Characteristics

Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
10 mg/m2
n=4 Participants
Ixabepilone
20 mg/m2
n=3 Participants
Ixabepilone
30 mg/m2
n=8 Participants
Ixabepilone
35 mg/m2
n=4 Participants
Ixabepilone
40 mg/m2
n=11 Participants
Ixabepilone
45 mg/m2
n=5 Participants
Ixabepilone
Total
n=35 Participants
Total of all reporting groups
Age, Continuous
63.5 years
n=5 Participants
59.0 years
n=7 Participants
61.5 years
n=5 Participants
59.5 years
n=4 Participants
58.0 years
n=21 Participants
52.0 years
n=8 Participants
59.0 years
n=8 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
0 Participants
n=7 Participants
5 Participants
n=5 Participants
2 Participants
n=4 Participants
5 Participants
n=21 Participants
3 Participants
n=8 Participants
16 Participants
n=8 Participants
Sex: Female, Male
Male
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
2 Participants
n=8 Participants
19 Participants
n=8 Participants
Race/Ethnicity, Customized
White
3 participants
n=5 Participants
2 participants
n=7 Participants
7 participants
n=5 Participants
3 participants
n=4 Participants
9 participants
n=21 Participants
2 participants
n=8 Participants
26 participants
n=8 Participants
Race/Ethnicity, Customized
Black
0 participants
n=5 Participants
1 participants
n=7 Participants
0 participants
n=5 Participants
1 participants
n=4 Participants
1 participants
n=21 Participants
2 participants
n=8 Participants
5 participants
n=8 Participants
Race/Ethnicity, Customized
Asian
1 participants
n=5 Participants
0 participants
n=7 Participants
1 participants
n=5 Participants
0 participants
n=4 Participants
1 participants
n=21 Participants
1 participants
n=8 Participants
4 participants
n=8 Participants
Karnofsky Performance Status
90 to 100
2 participants
n=5 Participants
2 participants
n=7 Participants
6 participants
n=5 Participants
2 participants
n=4 Participants
7 participants
n=21 Participants
3 participants
n=8 Participants
22 participants
n=8 Participants
Karnofsky Performance Status
70 to 80
2 participants
n=5 Participants
1 participants
n=7 Participants
2 participants
n=5 Participants
2 participants
n=4 Participants
4 participants
n=21 Participants
2 participants
n=8 Participants
13 participants
n=8 Participants
Karnofsky Performance Status
0 to 60
0 participants
n=5 Participants
0 participants
n=7 Participants
0 participants
n=5 Participants
0 participants
n=4 Participants
0 participants
n=21 Participants
0 participants
n=8 Participants
0 participants
n=8 Participants

PRIMARY outcome

Timeframe: Measures taken at Cycle 01 (21-day cycle)

Population: All treated participants

Dose limiting toxicities=any of the following events attributed to Ixabepilone occuring during the first cycle: grade 3/4 nausea, vomiting, or diarrhea despite medical intervention and/or prophylaxis; other Grade ≥3 nonhematological toxicity; any toxicity requiring study therapy discontinuation; delayed recovery from study therapy-related toxicity which delays scheduled re-treatment for \>14 days; Grade 4 neutropenia for ≥5 consecutive days; grade 3/4 neutropenia with sepsis or a fever ≥38.5 C; thrombocytopenia \<25,000 cells/mm3 or bleeding requiring a platelet transfusion.

Outcome measures

Outcome measures
Measure
10 mg/m2
n=4 Participants
Ixabepilone
20 mg/m2
n=3 Participants
Ixabepilone
30 mg/m2
n=8 Participants
Ixabepilone
35 mg/m2
n=4 Participants
Ixabepilone
40 mg/m2
n=11 Participants
Ixabepilone
45 mg/m2
n=5 Participants
Ixabepilone
Number of Participants With Dose Limiting Toxicities at Dose Level
0 participants
0 participants
0 participants
0 participants
1 participants
2 participants

SECONDARY outcome

Timeframe: From time of screening through post study follow-up at a maximum of 21 9-day cycles. Toxicity assessments occured at least every 4 weeks until all study drug related toxicities.

Adverse events (AEs) and Serious AEs (SAEs) considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).

Outcome measures

Outcome measures
Measure
10 mg/m2
n=35 Participants
Ixabepilone
20 mg/m2
n=35 Participants
Ixabepilone
30 mg/m2
n=35 Participants
Ixabepilone
35 mg/m2
Ixabepilone
40 mg/m2
Ixabepilone
45 mg/m2
Ixabepilone
Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
Any Treatment-Related AE
12 Participants
21 Participants
33 Participants
—
—
—
Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
Nausea
16 Participants
0 Participants
16 Participants
—
—
—
Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
Fatigue
14 Participants
2 Participants
16 Participants
—
—
—
Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
Alopecia
12 Participants
0 Participants
12 Participants
—
—
—
Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
Diarrhea
11 Participants
0 Participants
11 Participants
—
—
—
Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
Peripheral sensory neuropathy
9 Participants
0 Participants
9 Participants
—
—
—
Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
Stomatitis
9 Participants
0 Participants
9 Participants
—
—
—
Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
Any SAE
0 Participants
16 Participants
16 Participants
—
—
—
Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
Death within 30 days of last dose
0 Participants
1 Participants
1 Participants
—
—
—
Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
Any AE leading to discontinuation
0 Participants
5 Participants
5 Participants
—
—
—

SECONDARY outcome

Timeframe: Baseline (within 2 weeks of dosing), weekly, and within 72 hours prior to each subsequent 21-day cycle. If CTC Grade 4 hematologic toxicity is observed, complete blood count plus differential and platelets repeated every 3 days until resolution.

Worst on-study grade based on laboratory values graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).

Outcome measures

Outcome measures
Measure
10 mg/m2
n=35 Participants
Ixabepilone
20 mg/m2
n=35 Participants
Ixabepilone
30 mg/m2
n=35 Participants
Ixabepilone
35 mg/m2
n=35 Participants
Ixabepilone
40 mg/m2
n=35 Participants
Ixabepilone
45 mg/m2
Ixabepilone
Hematology Results - Worst On-Study Grade
White Blood Cells
5 Participants
5 Participants
8 Participants
10 Participants
7 Participants
—
Hematology Results - Worst On-Study Grade
Absolute Neutrophil Count
8 Participants
5 Participants
6 Participants
5 Participants
11 Participants
—
Hematology Results - Worst On-Study Grade
Hemoglobin
1 Participants
14 Participants
13 Participants
7 Participants
0 Participants
—
Hematology Results - Worst On-Study Grade
Platelets
21 Participants
9 Participants
0 Participants
3 Participants
2 Participants
—

SECONDARY outcome

Timeframe: through 72 hours after start of infusion

Population: All participants treated at the 40 mg/m2 dose level.

Mean concentrations over full time period for the 40 mg/mg2 dose level, established as the Maximum Tolerated Dose. (The Maximum Tolerated Dose was established as 40 mg/m2, based on an investiagtion of Dose Limiting Toxicities, which consisted of Febrile Neutropenia (at 40 mg/m2) in 1 participant and Grade 4 neutropenia lasting ≥5 days (at 45 mg/m2)in 2 participants.)

Outcome measures

Outcome measures
Measure
10 mg/m2
n=11 Participants
Ixabepilone
20 mg/m2
Ixabepilone
30 mg/m2
Ixabepilone
35 mg/m2
Ixabepilone
40 mg/m2
Ixabepilone
45 mg/m2
Ixabepilone
Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level
Hour 0.00 (n=11)
0 ng/mL
Standard Deviation 0
—
—
—
—
—
Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level
Hour 1.00 (n=11)
20.79 ng/mL
Standard Deviation 14.12
—
—
—
—
—
Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level
Hour 2.00 (n=11)
24.31 ng/mL
Standard Deviation 13.64
—
—
—
—
—
Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level
Hour 4.00 (n=11)
33.15 ng/mL
Standard Deviation 32.75
—
—
—
—
—
Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level
Hour 8.00 (n=11)
32.04 ng/mL
Standard Deviation 16.20
—
—
—
—
—
Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level
Hour 12.00 (n=11)
35.25 ng/mL
Standard Deviation 11.96
—
—
—
—
—
Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level
Hour 16.00 (n=11)
44.47 ng/mL
Standard Deviation 13.80
—
—
—
—
—
Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level
Hour 20.00 (n=11)
55.05 ng/mL
Standard Deviation 29.41
—
—
—
—
—
Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level
Hour 24.00 (n=11)
54.71 ng/mL
Standard Deviation 23.63
—
—
—
—
—
Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level
Hour 25.00 (n=10)
35.59 ng/mL
Standard Deviation 24.51
—
—
—
—
—
Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level
Hour 26.00 (n=10)
33.70 ng/mL
Standard Deviation 17.17
—
—
—
—
—
Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level
Hour 27.00 (n=10)
35.15 ng/mL
Standard Deviation 20.47
—
—
—
—
—
Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level
Hour 72.00 (n=10)
27.45 ng/mL
Standard Deviation 47.71
—
—
—
—
—

SECONDARY outcome

Timeframe: At Baseline (up to 2 weeks prior to starting therapy), after every 2nd cycle, and at post study follow-upn after a maximum of 9 cycles.

RECIST criteria, wherein complete response = disappearance of all target lesions; partial response = 30% decrease in the sum of the longest diameter of target lesions; progressive disease = 20% increase in the sum of the longest diameter of target lesions, and stable disease = small changes that do not meet above criteria.

Outcome measures

Outcome measures
Measure
10 mg/m2
n=35 Participants
Ixabepilone
20 mg/m2
Ixabepilone
30 mg/m2
Ixabepilone
35 mg/m2
Ixabepilone
40 mg/m2
Ixabepilone
45 mg/m2
Ixabepilone
Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST)
Complete Response
0 Participants
—
—
—
—
—
Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST)
Partial Response
0 Participants
—
—
—
—
—
Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST)
Stable Disease
14 Participants
—
—
—
—
—
Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive Disease
15 Participants
—
—
—
—
—
Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST)
Unable to Determine
6 Participants
—
—
—
—
—

Adverse Events

Ixa 10 mg/m2

Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths

Ixa 20 mg/m2

Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths

Ixa 30 mg/m2

Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths

Ixa 35 mg/m2

Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths

Ixa 40 mg/m2

Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths

Ixa 45 mg/m2

Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Ixa 10 mg/m2
n=4 participants at risk
Ixa 20 mg/m2
n=3 participants at risk
Ixa 30 mg/m2
n=8 participants at risk
Ixa 35 mg/m2
n=4 participants at risk
Ixa 40 mg/m2
n=11 participants at risk
Ixa 45 mg/m2
n=5 participants at risk
Investigations
NEUTROPHIL COUNT DECREASED
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Vascular disorders
HYPOTENSION
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Vascular disorders
DEEP VEIN THROMBOSIS
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Hepatobiliary disorders
CHOLECYSTITIS
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
0.00%
0/11
0.00%
0/5
Hepatobiliary disorders
HEPATORENAL SYNDROME
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Nervous system disorders
SYNCOPE
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Nervous system disorders
HEADACHE
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Nervous system disorders
DIZZINESS
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Nervous system disorders
HEMIPARESIS
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Nervous system disorders
HYPOAESTHESIA
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Gastrointestinal disorders
ILEUS
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Gastrointestinal disorders
NAUSEA
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Gastrointestinal disorders
VOMITING
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Gastrointestinal disorders
DIARRHOEA
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Infections and infestations
INFECTION
0.00%
0/4
0.00%
0/3
12.5%
1/8
25.0%
1/4
9.1%
1/11
0.00%
0/5
Infections and infestations
PNEUMONIA
25.0%
1/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Infections and infestations
UROSEPSIS
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Infections and infestations
CELLULITIS
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
0.00%
0/11
0.00%
0/5
Infections and infestations
SEPTIC SHOCK
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Renal and urinary disorders
RENAL FAILURE ACUTE
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
0.00%
0/11
0.00%
0/5
Metabolism and nutrition disorders
DEHYDRATION
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Metabolism and nutrition disorders
GLUCOSE TOLERANCE IMPAIRED
25.0%
1/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Blood and lymphatic system disorders
LEUKOPENIA
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Blood and lymphatic system disorders
NEUTROPENIA
0.00%
0/4
0.00%
0/3
12.5%
1/8
25.0%
1/4
9.1%
1/11
0.00%
0/5
Blood and lymphatic system disorders
THROMBOCYTOPENIA
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Congenital, familial and genetic disorders
TRACHEO-OESOPHAGEAL FISTULA
25.0%
1/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
0.00%
0/11
20.0%
1/5
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
0.00%
0/11
0.00%
0/5
Respiratory, thoracic and mediastinal disorders
COUGH
25.0%
1/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
General disorders
FATIGUE
25.0%
1/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
General disorders
CHEST PAIN
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM PROGRESSION
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5

Other adverse events

Other adverse events
Measure
Ixa 10 mg/m2
n=4 participants at risk
Ixa 20 mg/m2
n=3 participants at risk
Ixa 30 mg/m2
n=8 participants at risk
Ixa 35 mg/m2
n=4 participants at risk
Ixa 40 mg/m2
n=11 participants at risk
Ixa 45 mg/m2
n=5 participants at risk
General disorders
ASTHENIA
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
General disorders
CHEST PAIN
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
General disorders
FEELING COLD
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
General disorders
OEDEMA PERIPHERAL
25.0%
1/4
33.3%
1/3
25.0%
2/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
General disorders
MUCOSAL HAEMORRHAGE
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
General disorders
MUCOSAL INFLAMMATION
0.00%
0/4
0.00%
0/3
25.0%
2/8
0.00%
0/4
18.2%
2/11
20.0%
1/5
General disorders
NON-CARDIAC CHEST PAIN
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
General disorders
CATHETER RELATED COMPLICATION
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
0.00%
0/11
0.00%
0/5
Eye disorders
DRY EYE
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Eye disorders
ECTROPION
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Eye disorders
PHOTOPSIA
0.00%
0/4
33.3%
1/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Eye disorders
EYE OEDEMA
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Eye disorders
EYE IRRITATION
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Eye disorders
VISION BLURRED
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Eye disorders
ERYTHEMA OF EYELID
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Investigations
WEIGHT DECREASED
0.00%
0/4
33.3%
1/3
50.0%
4/8
25.0%
1/4
9.1%
1/11
20.0%
1/5
Investigations
HAEMOGLOBIN DECREASED
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
40.0%
2/5
Investigations
URINE OUTPUT DECREASED
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Investigations
BLOOD ALBUMIN DECREASED
25.0%
1/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Investigations
BLOOD CALCIUM DECREASED
25.0%
1/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Investigations
BLOOD GLUCOSE INCREASED
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Investigations
PLATELET COUNT DECREASED
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Investigations
BLOOD PHOSPHORUS DECREASED
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Investigations
NEUTROPHIL COUNT DECREASED
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Investigations
GASTRIC OCCULT BLOOD POSITIVE
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Investigations
WAIST CIRCUMFERENCE INCREASED
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Investigations
ELECTROCARDIOGRAM QT PROLONGED
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Investigations
WHITE BLOOD CELL COUNT DECREASED
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
9.1%
1/11
20.0%
1/5
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
25.0%
1/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Cardiac disorders
TACHYCARDIA
25.0%
1/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
0.00%
0/11
0.00%
0/5
Cardiac disorders
PALPITATIONS
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Vascular disorders
FLUSHING
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Vascular disorders
HYPOTENSION
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
18.2%
2/11
0.00%
0/5
Vascular disorders
HYPERTENSION
25.0%
1/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Psychiatric disorders
ANXIETY
0.00%
0/4
33.3%
1/3
25.0%
2/8
0.00%
0/4
18.2%
2/11
0.00%
0/5
Psychiatric disorders
INSOMNIA
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
18.2%
2/11
0.00%
0/5
Psychiatric disorders
AGITATION
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Psychiatric disorders
NIGHTMARE
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Psychiatric disorders
DEPRESSION
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
9.1%
1/11
20.0%
1/5
Psychiatric disorders
ABNORMAL DREAMS
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Psychiatric disorders
CONFUSIONAL STATE
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Psychiatric disorders
MENTAL STATUS CHANGES
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
18.2%
2/11
0.00%
0/5
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
40.0%
2/5
Nervous system disorders
TREMOR
0.00%
0/4
66.7%
2/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Nervous system disorders
APHASIA
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Nervous system disorders
HEADACHE
25.0%
1/4
33.3%
1/3
37.5%
3/8
25.0%
1/4
0.00%
0/11
40.0%
2/5
Nervous system disorders
DIZZINESS
0.00%
0/4
66.7%
2/3
12.5%
1/8
0.00%
0/4
18.2%
2/11
0.00%
0/5
Nervous system disorders
DYSGEUSIA
0.00%
0/4
66.7%
2/3
37.5%
3/8
25.0%
1/4
9.1%
1/11
0.00%
0/5
Nervous system disorders
PARAESTHESIA
0.00%
0/4
0.00%
0/3
12.5%
1/8
25.0%
1/4
9.1%
1/11
0.00%
0/5
Nervous system disorders
HYPOAESTHESIA
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Nervous system disorders
HYPERAESTHESIA
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Nervous system disorders
MENTAL IMPAIRMENT
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Nervous system disorders
SYNCOPE VASOVAGAL
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Nervous system disorders
RESTLESS LEGS SYNDROME
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
0.00%
0/4
33.3%
1/3
37.5%
3/8
25.0%
1/4
45.5%
5/11
20.0%
1/5
Gastrointestinal disorders
NAUSEA
50.0%
2/4
100.0%
3/3
87.5%
7/8
50.0%
2/4
54.5%
6/11
0.00%
0/5
Gastrointestinal disorders
LIP DRY
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
18.2%
2/11
0.00%
0/5
Gastrointestinal disorders
RETCHING
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Gastrointestinal disorders
VOMITING
0.00%
0/4
66.7%
2/3
50.0%
4/8
0.00%
0/4
27.3%
3/11
0.00%
0/5
Gastrointestinal disorders
CHEILITIS
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Gastrointestinal disorders
DIARRHOEA
0.00%
0/4
0.00%
0/3
62.5%
5/8
75.0%
3/4
54.5%
6/11
0.00%
0/5
Gastrointestinal disorders
DRY MOUTH
0.00%
0/4
33.3%
1/3
12.5%
1/8
0.00%
0/4
27.3%
3/11
0.00%
0/5
Gastrointestinal disorders
DYSPEPSIA
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Gastrointestinal disorders
DYSPHAGIA
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Gastrointestinal disorders
GLOSSITIS
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
9.1%
1/11
0.00%
0/5
Gastrointestinal disorders
ORAL PAIN
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Gastrointestinal disorders
TOOTHACHE
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Gastrointestinal disorders
FLATULENCE
25.0%
1/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Gastrointestinal disorders
STOMATITIS
0.00%
0/4
33.3%
1/3
37.5%
3/8
0.00%
0/4
36.4%
4/11
20.0%
1/5
Gastrointestinal disorders
LOOSE TOOTH
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Gastrointestinal disorders
ODYNOPHAGIA
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
0.00%
0/11
0.00%
0/5
Gastrointestinal disorders
CONSTIPATION
25.0%
1/4
66.7%
2/3
50.0%
4/8
25.0%
1/4
45.5%
5/11
40.0%
2/5
Gastrointestinal disorders
OESOPHAGITIS
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Gastrointestinal disorders
ABDOMINAL PAIN
0.00%
0/4
0.00%
0/3
37.5%
3/8
0.00%
0/4
18.2%
2/11
0.00%
0/5
Gastrointestinal disorders
MOUTH ULCERATION
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Gastrointestinal disorders
GINGIVAL ERYTHEMA
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Gastrointestinal disorders
HYPOAESTHESIA ORAL
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Gastrointestinal disorders
RECTAL HAEMORRHAGE
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Gastrointestinal disorders
STOMACH DISCOMFORT
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Gastrointestinal disorders
ABDOMINAL DISTENSION
50.0%
2/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
0.00%
0/4
0.00%
0/3
25.0%
2/8
25.0%
1/4
18.2%
2/11
0.00%
0/5
Gastrointestinal disorders
TONGUE DISCOLOURATION
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Gastrointestinal disorders
GASTROINTESTINAL DISORDER
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Gastrointestinal disorders
IMPAIRED GASTRIC EMPTYING
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Ear and labyrinth disorders
HYPOACUSIS
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Infections and infestations
RHINITIS
0.00%
0/4
33.3%
1/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Infections and infestations
INFECTION
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Infections and infestations
SINUSITIS
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
20.0%
1/5
Infections and infestations
CANDIDIASIS
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Infections and infestations
TINEA PEDIS
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Infections and infestations
FOLLICULITIS
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Infections and infestations
TOOTH INFECTION
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Infections and infestations
ORAL CANDIDIASIS
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
18.2%
2/11
0.00%
0/5
Infections and infestations
URINARY TRACT INFECTION
25.0%
1/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Renal and urinary disorders
NOCTURIA
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Renal and urinary disorders
POLLAKIURIA
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
0.00%
0/11
20.0%
1/5
Renal and urinary disorders
RENAL FAILURE
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
18.2%
2/11
0.00%
0/5
Renal and urinary disorders
ACUTE PRERENAL FAILURE
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Renal and urinary disorders
STRESS URINARY INCONTINENCE
25.0%
1/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Metabolism and nutrition disorders
ANOREXIA
0.00%
0/4
33.3%
1/3
50.0%
4/8
50.0%
2/4
18.2%
2/11
20.0%
1/5
Metabolism and nutrition disorders
DEHYDRATION
25.0%
1/4
0.00%
0/3
25.0%
2/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Metabolism and nutrition disorders
HYPOKALAEMIA
0.00%
0/4
0.00%
0/3
37.5%
3/8
0.00%
0/4
18.2%
2/11
20.0%
1/5
Metabolism and nutrition disorders
HYPERKALAEMIA
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Metabolism and nutrition disorders
HYPOCALCAEMIA
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Metabolism and nutrition disorders
HYPONATRAEMIA
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Metabolism and nutrition disorders
HYPERGLYCAEMIA
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
0.00%
0/4
0.00%
0/3
12.5%
1/8
25.0%
1/4
18.2%
2/11
0.00%
0/5
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
40.0%
2/5
Metabolism and nutrition disorders
DECREASED APPETITE
0.00%
0/4
33.3%
1/3
12.5%
1/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Blood and lymphatic system disorders
ANAEMIA
50.0%
2/4
0.00%
0/3
12.5%
1/8
25.0%
1/4
45.5%
5/11
40.0%
2/5
Blood and lymphatic system disorders
LEUKOPENIA
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Blood and lymphatic system disorders
NEUTROPENIA
0.00%
0/4
0.00%
0/3
50.0%
4/8
25.0%
1/4
63.6%
7/11
60.0%
3/5
Blood and lymphatic system disorders
THROMBOCYTOPENIA
25.0%
1/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
36.4%
4/11
0.00%
0/5
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
0.00%
0/11
0.00%
0/5
Skin and subcutaneous tissue disorders
ALOPECIA
0.00%
0/4
0.00%
0/3
75.0%
6/8
25.0%
1/4
45.5%
5/11
20.0%
1/5
Skin and subcutaneous tissue disorders
DRY SKIN
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
18.2%
2/11
0.00%
0/5
Skin and subcutaneous tissue disorders
PRURITUS
0.00%
0/4
33.3%
1/3
12.5%
1/8
0.00%
0/4
18.2%
2/11
0.00%
0/5
Skin and subcutaneous tissue disorders
URTICARIA
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Skin and subcutaneous tissue disorders
ONYCHOLYSIS
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Skin and subcutaneous tissue disorders
NIGHT SWEATS
25.0%
1/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Skin and subcutaneous tissue disorders
RASH PAPULAR
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Skin and subcutaneous tissue disorders
NAIL DISORDER
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Skin and subcutaneous tissue disorders
SKIN DISORDER
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
0.00%
0/11
0.00%
0/5
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
0.00%
0/11
0.00%
0/5
Skin and subcutaneous tissue disorders
SUBCUTANEOUS NODULE
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Reproductive system and breast disorders
VULVOVAGINAL PRURITUS
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
0.00%
0/11
0.00%
0/5
Injury, poisoning and procedural complications
CONTUSION
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Injury, poisoning and procedural complications
ANIMAL BITE
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Injury, poisoning and procedural complications
PROCEDURAL PAIN
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Musculoskeletal and connective tissue disorders
MYALGIA
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
36.4%
4/11
20.0%
1/5
Musculoskeletal and connective tissue disorders
BACK PAIN
25.0%
1/4
33.3%
1/3
12.5%
1/8
0.00%
0/4
36.4%
4/11
0.00%
0/5
Musculoskeletal and connective tissue disorders
BONE PAIN
25.0%
1/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
18.2%
2/11
0.00%
0/5
Musculoskeletal and connective tissue disorders
NECK PAIN
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
0.00%
0/11
0.00%
0/5
Musculoskeletal and connective tissue disorders
ARTHRALGIA
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
27.3%
3/11
20.0%
1/5
Musculoskeletal and connective tissue disorders
FLANK PAIN
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Musculoskeletal and connective tissue disorders
PAIN IN JAW
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
18.2%
2/11
20.0%
1/5
Musculoskeletal and connective tissue disorders
JOINT SWELLING
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
0.00%
0/4
33.3%
1/3
0.00%
0/8
0.00%
0/4
27.3%
3/11
0.00%
0/5
Musculoskeletal and connective tissue disorders
MOBILITY DECREASED
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Musculoskeletal and connective tissue disorders
SENSATION OF HEAVINESS
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Respiratory, thoracic and mediastinal disorders
COUGH
0.00%
0/4
33.3%
1/3
0.00%
0/8
100.0%
4/4
18.2%
2/11
40.0%
2/5
Respiratory, thoracic and mediastinal disorders
HYPOXIA
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
0.00%
0/11
20.0%
1/5
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
50.0%
2/4
0.00%
0/3
25.0%
2/8
25.0%
1/4
18.2%
2/11
20.0%
1/5
Respiratory, thoracic and mediastinal disorders
SNEEZING
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
0.00%
0/4
0.00%
0/3
12.5%
1/8
25.0%
1/4
0.00%
0/11
0.00%
0/5
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
0.00%
0/11
0.00%
0/5
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
0.00%
0/4
0.00%
0/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
0.00%
0/5
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
0.00%
0/11
20.0%
1/5
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
0.00%
0/4
0.00%
0/3
12.5%
1/8
0.00%
0/4
18.2%
2/11
0.00%
0/5
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
0.00%
0/4
0.00%
0/3
12.5%
1/8
25.0%
1/4
9.1%
1/11
0.00%
0/5
General disorders
PAIN
0.00%
0/4
33.3%
1/3
0.00%
0/8
25.0%
1/4
9.1%
1/11
0.00%
0/5
General disorders
CHILLS
50.0%
2/4
66.7%
2/3
0.00%
0/8
0.00%
0/4
9.1%
1/11
20.0%
1/5
General disorders
THIRST
0.00%
0/4
0.00%
0/3
0.00%
0/8
25.0%
1/4
0.00%
0/11
0.00%
0/5
General disorders
FATIGUE
25.0%
1/4
100.0%
3/3
75.0%
6/8
75.0%
3/4
72.7%
8/11
60.0%
3/5
General disorders
PYREXIA
0.00%
0/4
0.00%
0/3
25.0%
2/8
50.0%
2/4
18.2%
2/11
0.00%
0/5

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Results disclosure agreements

  • Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
  • Publication restrictions are in place

Restriction type: OTHER