Trial Outcomes & Findings for A Study of Ramucirumab (IMC-1121B) With Paclitaxel and Carboplatin in Non-small Cell Lung Cancer (NCT NCT00735696)
NCT ID: NCT00735696
Last Updated: 2014-12-29
Results Overview
Data presented are the percentage of participants without disease progression or death at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease was defined as having at least a 20% increase in sum of longest diameter of target lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
6 months
Results posted on
2014-12-29
Participant Flow
52 participants signed informed consent
Participant milestones
| Measure |
Ramucirumab + Paclitaxel + Carboplatin
ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m\^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
Received Any Quantity of Study Drug
|
40
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Ramucirumab + Paclitaxel + Carboplatin
ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m\^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Enrolled but never Treated
|
1
|
Baseline Characteristics
A Study of Ramucirumab (IMC-1121B) With Paclitaxel and Carboplatin in Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Ramucirumab + Paclitaxel + Carboplatin
n=40 Participants
ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m\^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants will receive ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants will continue to receive ramucirumab monotherapy every 3 weeks, provided there is ongoing evidence of benefit upon review every 6 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Modified intent to treat population (mITT): All participants who received any quantity of study drug. Nine participants were censored.
Data presented are the percentage of participants without disease progression or death at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease was defined as having at least a 20% increase in sum of longest diameter of target lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
Outcome measures
| Measure |
Ramucirumab + Paclitaxel + Carboplatin
n=40 Participants
ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m\^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks.
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|---|---|
|
Percentage of Participants Who Are Progression-free (PFS) at 6 Months
|
59.0 percentage of participants
Interval 41.3 to 72.9
|
SECONDARY outcome
Timeframe: Baseline up to 32.5 monthsPopulation: Safety Population: All participants who received any quantity of study drug.
Data presented are the number of participants who experienced ramucirumab related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of ramucirumab treatment, and any TEAE leading to dose modification ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section.
Outcome measures
| Measure |
Ramucirumab + Paclitaxel + Carboplatin
n=40 Participants
ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m\^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks.
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|---|---|
|
Summary of Participants Reporting Adverse Events
Any ramucirumab related TEAE
|
34 participants
|
|
Summary of Participants Reporting Adverse Events
Any ramucirumab related Serious TEAE
|
8 participants
|
|
Summary of Participants Reporting Adverse Events
Any ramucirumab related Grade >= 3 TEAE
|
15 participants
|
|
Summary of Participants Reporting Adverse Events
Any TEAE Leading to Discontinuation of ramucirumab
|
13 participants
|
|
Summary of Participants Reporting Adverse Events
TEAE Leading to Dose Modification of ramucirumab
|
24 participants
|
|
Summary of Participants Reporting Adverse Events
Any ramucirumab related TEAE with Outcome of Death
|
0 participants
|
SECONDARY outcome
Timeframe: First dose to measured progressive disease or death due to any cause up to 32.5 monthsPopulation: Modified intent to treat population (mITT): All participants who received any quantity of study drug.
Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100.
Outcome measures
| Measure |
Ramucirumab + Paclitaxel + Carboplatin
n=40 Participants
ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m\^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks.
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|---|---|
|
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate ([ORR])
|
55.0 percentage of participants
Interval 38.5 to 70.7
|
SECONDARY outcome
Timeframe: First dose up to 32.5 monthsPopulation: Participants who had tumor response. Two participants who had tumor response did not progress by the data cut-off date, therefore were censored for duration of response analysis.
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression, initiation of additional antitumor therapy is first reported, or death as a result of any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions.
Outcome measures
| Measure |
Ramucirumab + Paclitaxel + Carboplatin
n=22 Participants
ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m\^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks.
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|---|---|
|
Duration of Response
|
5.54 months
Interval 4.27 to 8.21
|
SECONDARY outcome
Timeframe: First dose to 1 yearPopulation: Modified intent to treat population (mITT): All participants who received any quantity of study drug.
Data presented are the percentage of participants surviving at least 12 months after first dose of study medication.
Outcome measures
| Measure |
Ramucirumab + Paclitaxel + Carboplatin
n=40 Participants
ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m\^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks.
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|---|---|
|
Overall Survival (OS) at 1 Year
|
74.6 percentage of participants
Interval 57.9 to 85.4
|
SECONDARY outcome
Timeframe: First dose to measured progressive disease or death due to any cause, up to 32.5 monthsPopulation: Modified intent to treat population (mITT): All participants who received any quantity of study drug. Nine participants were censored.
Defined as the time from date of first dose of study medication to the first documented disease progression as defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.0), initiation of additional antitumor therapy was first reported or death due to any cause. Participants who did not progress, who discontinued treatment for toxicity or a reason other than documented progression, or who were lost to follow-up before documented progression or death were censored at date of last tumor assessment. Participants who started new therapeutic anticancer treatment prior to documented progression or death were censored at date of last tumor assessment prior to new therapeutic anticancer therapy.
Outcome measures
| Measure |
Ramucirumab + Paclitaxel + Carboplatin
n=40 Participants
ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m\^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks.
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|---|---|
|
Progression-free Survival (PFS)
|
7.85 months
Interval 5.49 to 9.86
|
SECONDARY outcome
Timeframe: First dose to death due to any cause, up to 32.5 monthsPopulation: Modified intent to treat population (mITT): All participants who received any quantity of study drug. Fourteen participants were censored.
Overall survival is defined as the time from the first dose of study medication to the date of death from any cause. Participants who were alive at the end of the follow-up period or lost to follow-up were censored on the last date the patient was known to be alive.
Outcome measures
| Measure |
Ramucirumab + Paclitaxel + Carboplatin
n=40 Participants
ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m\^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks.
|
|---|---|
|
Overall Survival (OS)
|
16.85 months
Interval 14.82 to 28.58
|
SECONDARY outcome
Timeframe: Week 15 (Cycle 5)Population: Participants who had Anti-Ramucirumab Antibody assessment at week 15 (cycle 5).
The number of participants who developed treatment emergent antibody responses to ramucirumab after baseline.
Outcome measures
| Measure |
Ramucirumab + Paclitaxel + Carboplatin
n=29 Participants
ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m\^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks.
|
|---|---|
|
Serum Anti-Ramucirumab Antibody Assessment
|
1 participants
|
SECONDARY outcome
Timeframe: Week 18 (Cycle 6), at 1-Hour Post End of InfusionPopulation: Participants who received any quantity of study medication and had evaluable concentration data at the specified time point.
Outcome measures
| Measure |
Ramucirumab + Paclitaxel + Carboplatin
n=8 Participants
ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m\^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks.
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|---|---|
|
Maximum Concentration of Ramucirumab (Cmax)
|
372 micrograms/milliliter (mcg/mL)
Standard Deviation 82.9
|
Adverse Events
Ramucirumab + Paclitaxel + Carboplatin
Serious events: 19 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ramucirumab + Paclitaxel + Carboplatin
n=40 participants at risk
ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m\^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks.
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|---|---|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
10.0%
4/40 • Number of events 5
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
5.0%
2/40 • Number of events 2
|
|
Gastrointestinal disorders
NAUSEA
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
2.5%
1/40 • Number of events 1
|
|
General disorders
CHILLS
|
2.5%
1/40 • Number of events 1
|
|
General disorders
FATIGUE
|
2.5%
1/40 • Number of events 1
|
|
General disorders
INFUSION RELATED REACTION
|
2.5%
1/40 • Number of events 1
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
2.5%
1/40 • Number of events 1
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
CATHETER SEPSIS
|
5.0%
2/40 • Number of events 2
|
|
Infections and infestations
EMPYEMA
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
PERIANAL ABSCESS
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
SINUSITIS
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
CONVULSION
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
DIZZINESS
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
SYNCOPE VASOVAGAL
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
ANXIETY
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
2.5%
1/40 • Number of events 1
|
Other adverse events
| Measure |
Ramucirumab + Paclitaxel + Carboplatin
n=40 participants at risk
ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m\^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
12.5%
5/40 • Number of events 6
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
5.0%
2/40 • Number of events 2
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
7.5%
3/40 • Number of events 4
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
32.5%
13/40 • Number of events 28
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
32.5%
13/40 • Number of events 42
|
|
Cardiac disorders
TACHYCARDIA
|
5.0%
2/40 • Number of events 3
|
|
Eye disorders
VISION BLURRED
|
5.0%
2/40 • Number of events 2
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
5.0%
2/40 • Number of events 2
|
|
Gastrointestinal disorders
CONSTIPATION
|
40.0%
16/40 • Number of events 24
|
|
Gastrointestinal disorders
DIARRHOEA
|
35.0%
14/40 • Number of events 19
|
|
Gastrointestinal disorders
DRY MOUTH
|
5.0%
2/40 • Number of events 2
|
|
Gastrointestinal disorders
DYSPEPSIA
|
7.5%
3/40 • Number of events 4
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
15.0%
6/40 • Number of events 6
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
5.0%
2/40 • Number of events 2
|
|
Gastrointestinal disorders
NAUSEA
|
57.5%
23/40 • Number of events 38
|
|
Gastrointestinal disorders
STOMATITIS
|
15.0%
6/40 • Number of events 6
|
|
Gastrointestinal disorders
VOMITING
|
35.0%
14/40 • Number of events 14
|
|
General disorders
ASTHENIA
|
5.0%
2/40 • Number of events 4
|
|
General disorders
CHILLS
|
5.0%
2/40 • Number of events 2
|
|
General disorders
FATIGUE
|
72.5%
29/40 • Number of events 58
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
5.0%
2/40 • Number of events 3
|
|
General disorders
INFUSION RELATED REACTION
|
17.5%
7/40 • Number of events 10
|
|
General disorders
MUCOSAL INFLAMMATION
|
5.0%
2/40 • Number of events 2
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
22.5%
9/40 • Number of events 9
|
|
General disorders
OEDEMA PERIPHERAL
|
27.5%
11/40 • Number of events 12
|
|
General disorders
PAIN
|
5.0%
2/40 • Number of events 2
|
|
General disorders
PYREXIA
|
10.0%
4/40 • Number of events 6
|
|
General disorders
TEMPERATURE INTOLERANCE
|
5.0%
2/40 • Number of events 5
|
|
Infections and infestations
CELLULITIS
|
7.5%
3/40 • Number of events 3
|
|
Infections and infestations
FOLLICULITIS
|
7.5%
3/40 • Number of events 5
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.0%
2/40 • Number of events 3
|
|
Infections and infestations
PNEUMONIA
|
5.0%
2/40 • Number of events 2
|
|
Infections and infestations
TOOTH ABSCESS
|
5.0%
2/40 • Number of events 2
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.5%
3/40 • Number of events 3
|
|
Infections and infestations
URINARY TRACT INFECTION
|
10.0%
4/40 • Number of events 4
|
|
Investigations
WEIGHT DECREASED
|
17.5%
7/40 • Number of events 10
|
|
Metabolism and nutrition disorders
ANOREXIA
|
25.0%
10/40 • Number of events 12
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
12.5%
5/40 • Number of events 6
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
12.5%
5/40 • Number of events 5
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
5.0%
2/40 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
40.0%
16/40 • Number of events 21
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.5%
3/40 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
7.5%
3/40 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
5.0%
2/40 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
7.5%
3/40 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
5.0%
2/40 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
27.5%
11/40 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
5.0%
2/40 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
7.5%
3/40 • Number of events 9
|
|
Nervous system disorders
BALANCE DISORDER
|
5.0%
2/40 • Number of events 2
|
|
Nervous system disorders
DIZZINESS
|
12.5%
5/40 • Number of events 6
|
|
Nervous system disorders
DYSGEUSIA
|
15.0%
6/40 • Number of events 6
|
|
Nervous system disorders
HEADACHE
|
27.5%
11/40 • Number of events 14
|
|
Nervous system disorders
HYPOAESTHESIA
|
7.5%
3/40 • Number of events 5
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
67.5%
27/40 • Number of events 44
|
|
Nervous system disorders
SYNCOPE
|
5.0%
2/40 • Number of events 2
|
|
Psychiatric disorders
ANXIETY
|
17.5%
7/40 • Number of events 7
|
|
Psychiatric disorders
DEPRESSION
|
12.5%
5/40 • Number of events 6
|
|
Psychiatric disorders
INSOMNIA
|
10.0%
4/40 • Number of events 4
|
|
Renal and urinary disorders
PROTEINURIA
|
10.0%
4/40 • Number of events 10
|
|
Reproductive system and breast disorders
PELVIC DISCOMFORT
|
5.0%
2/40 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
25.0%
10/40 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
10.0%
4/40 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
22.5%
9/40 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
12.5%
5/40 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
30.0%
12/40 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
7.5%
3/40 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
5.0%
2/40 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
7.5%
3/40 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DRYNESS
|
5.0%
2/40 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
ORTHOPNOEA
|
5.0%
2/40 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
10.0%
4/40 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
10.0%
4/40 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
57.5%
23/40 • Number of events 37
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
7.5%
3/40 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
5.0%
2/40 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
15.0%
6/40 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
5.0%
2/40 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
NAIL DISCOLOURATION
|
5.0%
2/40 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
5.0%
2/40 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
5.0%
2/40 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
RASH
|
20.0%
8/40 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
5.0%
2/40 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
7.5%
3/40 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
5.0%
2/40 • Number of events 2
|
|
Vascular disorders
HYPERTENSION
|
15.0%
6/40 • Number of events 6
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
5.0%
2/40 • Number of events 2
|
|
Vascular disorders
PHLEBITIS
|
5.0%
2/40 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER