Trial Outcomes & Findings for Pemetrexed Plus Gemcitabine in Metastatic Breast Cancer Patients After Receiving Taxane Therapy (NCT NCT00063570)
NCT ID: NCT00063570
Last Updated: 2009-05-29
Results Overview
Best overall (confirmed) response recorded from start of treatment until disease progression/recurrence, start of other anti-tumor therapy/intervention, or end of trial, whichever comes first. Response must be confirmed at least 6 weeks from previous scans. Best overall response assignment depends on both measurement and confirmation criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated
Results posted on
2009-05-29
Participant Flow
At completion of the first stage of the trial, toxicities associated with the Day 8 dosing of gemcitabine were observed, and the protocol was amended to a bi-weekly schedule. Patients were analyzed separately according to the study drug schedule received.
Participant milestones
| Measure |
Bi-Weekly Schedule
Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.
|
21-Day Schedule
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
21
|
|
Overall Study
COMPLETED
|
52
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pemetrexed Plus Gemcitabine in Metastatic Breast Cancer Patients After Receiving Taxane Therapy
Baseline characteristics by cohort
| Measure |
Bi-Weekly Schedule
n=52 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.
|
21-Day Schedule
n=21 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
53.5 years
n=93 Participants
|
50.7 years
n=4 Participants
|
51.9 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=93 Participants
|
21 participants
n=4 Participants
|
73 participants
n=27 Participants
|
|
Current Pathological Diagnosis
Ductal breast carcinoma
|
36 paticipants
n=93 Participants
|
12 paticipants
n=4 Participants
|
48 paticipants
n=27 Participants
|
|
Current Pathological Diagnosis
Lobular breast carcinoma
|
2 paticipants
n=93 Participants
|
0 paticipants
n=4 Participants
|
2 paticipants
n=27 Participants
|
|
Current Pathological Diagnosis
Adenocystic breast carcinoma
|
0 paticipants
n=93 Participants
|
1 paticipants
n=4 Participants
|
1 paticipants
n=27 Participants
|
|
Current Pathological Diagnosis
Breast carcinoma
|
4 paticipants
n=93 Participants
|
4 paticipants
n=4 Participants
|
8 paticipants
n=27 Participants
|
|
Current Pathological Diagnosis
Other
|
7 paticipants
n=93 Participants
|
3 paticipants
n=4 Participants
|
10 paticipants
n=27 Participants
|
|
Current Pathological Diagnosis
Unknown
|
1 paticipants
n=93 Participants
|
1 paticipants
n=4 Participants
|
2 paticipants
n=27 Participants
|
|
Current Pathological Diagnosis
No current pathological diagnosis
|
2 paticipants
n=93 Participants
|
0 paticipants
n=4 Participants
|
2 paticipants
n=27 Participants
|
|
Karnofsky Performance Status (KPS)
<=60 - Needs increasing assistance up to Death (0)
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Karnofsky Performance Status (KPS)
70 - Unable to carry on normal activity
|
4 participants
n=93 Participants
|
1 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Karnofsky Performance Status (KPS)
80 - Activity with effort; some signs of disease
|
11 participants
n=93 Participants
|
5 participants
n=4 Participants
|
16 participants
n=27 Participants
|
|
Karnofsky Performance Status (KPS)
90 - Normal activity; minor signs of disease
|
19 participants
n=93 Participants
|
9 participants
n=4 Participants
|
28 participants
n=27 Participants
|
|
Karnofsky Performance Status (KPS)
100 - Normal no complaints; no evidence of disease
|
17 participants
n=93 Participants
|
6 participants
n=4 Participants
|
23 participants
n=27 Participants
|
|
Karnofsky Performance Status (KPS)
unknown
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Menopausal Status at Cycle 0
Pre-Menopausal
|
7 participants
n=93 Participants
|
3 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Menopausal Status at Cycle 0
Menopausal
|
4 participants
n=93 Participants
|
3 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Menopausal Status at Cycle 0
Post-Menopausal
|
41 participants
n=93 Participants
|
15 participants
n=4 Participants
|
56 participants
n=27 Participants
|
|
Patients with Current Pathological Diagnosis
Yes
|
50 participants
n=93 Participants
|
21 participants
n=4 Participants
|
71 participants
n=27 Participants
|
|
Patients with Current Pathological Diagnosis
No
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Race/Ethnicity
Caucasian
|
44 participants
n=93 Participants
|
20 participants
n=4 Participants
|
64 participants
n=27 Participants
|
|
Race/Ethnicity
African
|
4 participants
n=93 Participants
|
1 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Race/Ethnicity
East/Southeast Asian
|
3 participants
n=93 Participants
|
0 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Race/Ethnicity
Hispanic
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Time (in months) from Current Pathological Diagnosis to Enrollment
|
13.08 Months
n=93 Participants
|
14.31 Months
n=4 Participants
|
14.29 Months
n=27 Participants
|
PRIMARY outcome
Timeframe: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicatedPopulation: Patients who received at least one dose of study drug (pemetrexed or gemcitabine) were included in the analyses.
Best overall (confirmed) response recorded from start of treatment until disease progression/recurrence, start of other anti-tumor therapy/intervention, or end of trial, whichever comes first. Response must be confirmed at least 6 weeks from previous scans. Best overall response assignment depends on both measurement and confirmation criteria.
Outcome measures
| Measure |
Bi-Weekly Schedule
n=52 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.
|
21-Day Schedule
n=21 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.
|
|---|---|---|
|
Overall Tumor Response
Complete Response
|
2 participants
|
0 participants
|
|
Overall Tumor Response
Partial Response
|
8 participants
|
5 participants
|
|
Overall Tumor Response
Stable Disease
|
26 participants
|
10 participants
|
|
Overall Tumor Response
Progressive Disease
|
14 participants
|
6 participants
|
|
Overall Tumor Response
Unknown
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicatedPopulation: Number of patients with a confirmed complete or partial response.
Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed CR or PR + 1)/(365.25/12).
Outcome measures
| Measure |
Bi-Weekly Schedule
n=10 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.
|
21-Day Schedule
n=5 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.
|
|---|---|---|
|
Duration of (Confirmed) Complete Response or Partial Response
|
5.85 months
Interval 2.79 to 16.79
|
4.17 months
Interval 3.71 to 17.61
|
SECONDARY outcome
Timeframe: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicatedPopulation: Intention to Treat analysis
Time to progressive disease is calculated as (Date of First Disease Progression or Death Due to Disease under Study whichever Comes First - First Dose Date + 1)/(365.25/12).
Outcome measures
| Measure |
Bi-Weekly Schedule
n=52 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.
|
21-Day Schedule
n=21 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.
|
|---|---|---|
|
Time to Progressive Disease
|
3.19 months
Interval 0.16 to 18.2
|
4.01 months
Interval 1.05 to 20.8
|
SECONDARY outcome
Timeframe: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicatedPopulation: Intention to Treat analysis
Time to treatment failure is calculated as (Date of First Disease Progression, Death as a Result of any Cause, or Early Discontinuation of Treatment Due to Adverse Event or Physician Perception of Lack of Efficacy or Patient and Physician Perception of Lack of Efficacy, whichever Comes First - First Dose Date + 1)/ (365.25/12)
Outcome measures
| Measure |
Bi-Weekly Schedule
n=52 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.
|
21-Day Schedule
n=21 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.
|
|---|---|---|
|
Time to Treatment Failure
|
2.79 months
Interval 0.16 to 18.2
|
2.56 months
Interval 0.49 to 20.8
|
SECONDARY outcome
Timeframe: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicatedOverall survival time is calculated as (Date of Death as a Result of any Cause - First Dose Date + 1)/ (365.25/12).
Outcome measures
| Measure |
Bi-Weekly Schedule
n=52 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.
|
21-Day Schedule
n=21 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.
|
|---|---|---|
|
Overall Survival
|
13.44 months
Interval 0.76 to 36.6
|
16.20 months
Interval 1.41 to 31.64
|
Adverse Events
Bi-Weekly Schedule
Serious events: 17 serious events
Other events: 51 other events
Deaths: 0 deaths
21-Day Schedule
Serious events: 7 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bi-Weekly Schedule
Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.
|
21-Day Schedule
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
2/52 • Number of events 2
|
0.00%
0/21
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
4/52 • Number of events 5
|
4.8%
1/21 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/52
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Pyrexia
|
3.8%
2/52 • Number of events 3
|
4.8%
1/21 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic failure
|
1.9%
1/52 • Number of events 2
|
0.00%
0/21
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Device related infection
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Pneumonia
|
3.8%
2/52 • Number of events 2
|
0.00%
0/21
|
|
Infections and infestations
Sepsis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/52
|
4.8%
1/21 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Investigations
Drug level increased
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
2/52 • Number of events 2
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Nervous system disorders
Convulsion
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Nervous system disorders
Dizziness
|
0.00%
0/52
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Lumbar radiculopathy
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Nervous system disorders
Meningitis noninfective
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Psychiatric disorders
Mental status changes
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/52
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
2/52 • Number of events 2
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/52
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/52
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
1.9%
1/52 • Number of events 1
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/52
|
4.8%
1/21 • Number of events 1
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/52
|
4.8%
1/21 • Number of events 1
|
|
Vascular disorders
Superior vena caval occlusion
|
0.00%
0/52
|
4.8%
1/21 • Number of events 1
|
Other adverse events
| Measure |
Bi-Weekly Schedule
Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.
|
21-Day Schedule
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
44.2%
23/52 • Number of events 40
|
57.1%
12/21 • Number of events 22
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.8%
2/52 • Number of events 2
|
14.3%
3/21 • Number of events 3
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
13/52 • Number of events 18
|
28.6%
6/21 • Number of events 22
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.9%
1/52 • Number of events 2
|
9.5%
2/21 • Number of events 10
|
|
Blood and lymphatic system disorders
Neutropenia
|
44.2%
23/52 • Number of events 35
|
76.2%
16/21 • Number of events 53
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
1.9%
1/52 • Number of events 1
|
9.5%
2/21 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
19.2%
10/52 • Number of events 14
|
38.1%
8/21 • Number of events 20
|
|
Cardiac disorders
Tachycardia
|
9.6%
5/52 • Number of events 5
|
4.8%
1/21 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.00%
0/52
|
9.5%
2/21 • Number of events 4
|
|
Eye disorders
Eye irritation
|
7.7%
4/52 • Number of events 4
|
14.3%
3/21 • Number of events 4
|
|
Eye disorders
Eye swelling
|
5.8%
3/52 • Number of events 3
|
0.00%
0/21
|
|
Eye disorders
Lacrimation increased
|
15.4%
8/52 • Number of events 9
|
4.8%
1/21 • Number of events 1
|
|
Eye disorders
Vision blurred
|
5.8%
3/52 • Number of events 3
|
0.00%
0/21
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.8%
3/52 • Number of events 3
|
0.00%
0/21
|
|
Gastrointestinal disorders
Abdominal distension
|
9.6%
5/52 • Number of events 7
|
14.3%
3/21 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
19.2%
10/52 • Number of events 13
|
23.8%
5/21 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.6%
5/52 • Number of events 6
|
0.00%
0/21
|
|
Gastrointestinal disorders
Constipation
|
50.0%
26/52 • Number of events 40
|
28.6%
6/21 • Number of events 11
|
|
Gastrointestinal disorders
Diarrhoea
|
30.8%
16/52 • Number of events 18
|
57.1%
12/21 • Number of events 14
|
|
Gastrointestinal disorders
Dry mouth
|
5.8%
3/52 • Number of events 6
|
0.00%
0/21
|
|
Gastrointestinal disorders
Dyspepsia
|
9.6%
5/52 • Number of events 5
|
14.3%
3/21 • Number of events 3
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.5%
6/52 • Number of events 6
|
0.00%
0/21
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.8%
3/52 • Number of events 3
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
53.8%
28/52 • Number of events 46
|
66.7%
14/21 • Number of events 28
|
|
Gastrointestinal disorders
Stomatitis
|
17.3%
9/52 • Number of events 12
|
14.3%
3/21 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
19.2%
10/52 • Number of events 13
|
33.3%
7/21 • Number of events 16
|
|
General disorders
Asthenia
|
11.5%
6/52 • Number of events 9
|
19.0%
4/21 • Number of events 6
|
|
General disorders
Chest discomfort
|
5.8%
3/52 • Number of events 5
|
4.8%
1/21 • Number of events 2
|
|
General disorders
Chest pain
|
7.7%
4/52 • Number of events 4
|
19.0%
4/21 • Number of events 5
|
|
General disorders
Chills
|
13.5%
7/52 • Number of events 9
|
28.6%
6/21 • Number of events 7
|
|
General disorders
Face oedema
|
7.7%
4/52 • Number of events 4
|
0.00%
0/21
|
|
General disorders
Fatigue
|
67.3%
35/52 • Number of events 68
|
71.4%
15/21 • Number of events 28
|
|
General disorders
Feeling hot
|
0.00%
0/52
|
9.5%
2/21 • Number of events 2
|
|
General disorders
Mucosal inflammation
|
11.5%
6/52 • Number of events 7
|
19.0%
4/21 • Number of events 4
|
|
General disorders
Oedema
|
9.6%
5/52 • Number of events 6
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Oedema peripheral
|
23.1%
12/52 • Number of events 15
|
19.0%
4/21 • Number of events 5
|
|
General disorders
Pain
|
9.6%
5/52 • Number of events 6
|
14.3%
3/21 • Number of events 4
|
|
General disorders
Pyrexia
|
28.8%
15/52 • Number of events 23
|
66.7%
14/21 • Number of events 25
|
|
Immune system disorders
Hypersensitivity
|
5.8%
3/52 • Number of events 4
|
0.00%
0/21
|
|
Infections and infestations
Cellulitis
|
5.8%
3/52 • Number of events 3
|
0.00%
0/21
|
|
Infections and infestations
Sinusitis
|
5.8%
3/52 • Number of events 3
|
9.5%
2/21 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
9.6%
5/52 • Number of events 7
|
14.3%
3/21 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
7.7%
4/52 • Number of events 6
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
23.1%
12/52 • Number of events 15
|
33.3%
7/21 • Number of events 17
|
|
Investigations
Aspartate aminotransferase increased
|
26.9%
14/52 • Number of events 17
|
42.9%
9/21 • Number of events 19
|
|
Investigations
Blood alkaline phosphatase increased
|
11.5%
6/52 • Number of events 6
|
23.8%
5/21 • Number of events 7
|
|
Investigations
Haemoglobin decreased
|
7.7%
4/52 • Number of events 5
|
9.5%
2/21 • Number of events 7
|
|
Investigations
Neutrophil count decreased
|
3.8%
2/52 • Number of events 2
|
19.0%
4/21 • Number of events 4
|
|
Investigations
Weight decreased
|
5.8%
3/52 • Number of events 3
|
0.00%
0/21
|
|
Investigations
White blood cell count decreased
|
0.00%
0/52
|
14.3%
3/21 • Number of events 5
|
|
Metabolism and nutrition disorders
Anorexia
|
19.2%
10/52 • Number of events 11
|
38.1%
8/21 • Number of events 12
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.8%
2/52 • Number of events 3
|
9.5%
2/21 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/52 • Number of events 1
|
9.5%
2/21 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
21.2%
11/52 • Number of events 16
|
9.5%
2/21 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.9%
1/52 • Number of events 1
|
9.5%
2/21 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.8%
2/52 • Number of events 2
|
9.5%
2/21 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.5%
6/52 • Number of events 9
|
28.6%
6/21 • Number of events 9
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
4/52 • Number of events 5
|
14.3%
3/21 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.3%
9/52 • Number of events 11
|
28.6%
6/21 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
8/52 • Number of events 8
|
23.8%
5/21 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.8%
3/52 • Number of events 4
|
14.3%
3/21 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/52
|
9.5%
2/21 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
11.5%
6/52 • Number of events 6
|
4.8%
1/21 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.8%
3/52 • Number of events 5
|
19.0%
4/21 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.5%
7/52 • Number of events 14
|
23.8%
5/21 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
4/52 • Number of events 5
|
28.6%
6/21 • Number of events 7
|
|
Nervous system disorders
Dizziness
|
5.8%
3/52 • Number of events 3
|
19.0%
4/21 • Number of events 5
|
|
Nervous system disorders
Dysgeusia
|
9.6%
5/52 • Number of events 8
|
9.5%
2/21 • Number of events 2
|
|
Nervous system disorders
Headache
|
21.2%
11/52 • Number of events 17
|
52.4%
11/21 • Number of events 12
|
|
Nervous system disorders
Hypoaesthesia
|
5.8%
3/52 • Number of events 3
|
14.3%
3/21 • Number of events 3
|
|
Nervous system disorders
Lethargy
|
3.8%
2/52 • Number of events 2
|
9.5%
2/21 • Number of events 3
|
|
Nervous system disorders
Neuropathy peripheral
|
5.8%
3/52 • Number of events 3
|
14.3%
3/21 • Number of events 3
|
|
Nervous system disorders
Paraesthesia
|
5.8%
3/52 • Number of events 3
|
14.3%
3/21 • Number of events 4
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/52
|
9.5%
2/21 • Number of events 2
|
|
Nervous system disorders
Somnolence
|
0.00%
0/52
|
9.5%
2/21 • Number of events 2
|
|
Nervous system disorders
Tremor
|
5.8%
3/52 • Number of events 3
|
0.00%
0/21
|
|
Psychiatric disorders
Anxiety
|
11.5%
6/52 • Number of events 6
|
14.3%
3/21 • Number of events 4
|
|
Psychiatric disorders
Confusional state
|
7.7%
4/52 • Number of events 5
|
0.00%
0/21
|
|
Psychiatric disorders
Insomnia
|
17.3%
9/52 • Number of events 9
|
14.3%
3/21 • Number of events 3
|
|
Renal and urinary disorders
Dysuria
|
5.8%
3/52 • Number of events 3
|
4.8%
1/21 • Number of events 1
|
|
Reproductive system and breast disorders
Breast pain
|
1.9%
1/52 • Number of events 1
|
9.5%
2/21 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.9%
14/52 • Number of events 15
|
33.3%
7/21 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
28.8%
15/52 • Number of events 20
|
28.6%
6/21 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
9.6%
5/52 • Number of events 6
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.6%
5/52 • Number of events 5
|
9.5%
2/21 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.8%
3/52 • Number of events 3
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.8%
3/52 • Number of events 3
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
5.8%
3/52 • Number of events 5
|
19.0%
4/21 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.8%
2/52 • Number of events 2
|
23.8%
5/21 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.8%
2/52 • Number of events 2
|
9.5%
2/21 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/52
|
9.5%
2/21 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.4%
8/52 • Number of events 8
|
14.3%
3/21 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.6%
5/52 • Number of events 6
|
4.8%
1/21 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.6%
5/52 • Number of events 6
|
19.0%
4/21 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.6%
5/52 • Number of events 5
|
14.3%
3/21 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.3%
9/52 • Number of events 10
|
19.0%
4/21 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash
|
44.2%
23/52 • Number of events 30
|
71.4%
15/21 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
5.8%
3/52 • Number of events 4
|
4.8%
1/21 • Number of events 1
|
|
Vascular disorders
Flushing
|
1.9%
1/52 • Number of events 1
|
28.6%
6/21 • Number of events 6
|
|
Vascular disorders
Lymphoedema
|
11.5%
6/52 • Number of events 9
|
9.5%
2/21 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60