Trial Outcomes & Findings for A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Having Received Tarceva Monotherapy. (NCT NCT00773383)
NCT ID: NCT00773383
Last Updated: 2013-06-24
Results Overview
The primary efficacy endpoint is progression-free survival at 12 weeks after start of therapy. A progression-free survival rate at 12 weeks will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 weeks.
TERMINATED
PHASE2
35 participants
12 weeks
2013-06-24
Participant Flow
Participant milestones
| Measure |
R1507
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
Received Study Drug
|
34
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
R1507
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Death
|
1
|
|
Overall Study
Progression of Disease
|
23
|
|
Overall Study
Other
|
2
|
|
Overall Study
No study dose received
|
1
|
Baseline Characteristics
A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Having Received Tarceva Monotherapy.
Baseline characteristics by cohort
| Measure |
R1507
n=34 Participants
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
|
|---|---|
|
Age Continuous
|
59.9 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: All Treated Population
The primary efficacy endpoint is progression-free survival at 12 weeks after start of therapy. A progression-free survival rate at 12 weeks will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 weeks.
Outcome measures
| Measure |
R1507
n=34 Participants
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
|
R1507_Baseline Impaired Fasting Glucose
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
Includes all participants with a fasting glucose at baseline ≥ 110 to \< 126 mg/dL
|
R1507_Baseline Diabetes Mellitus
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
Includes all participants with a fasting glucose at baseline ≥ 126 mg/dL
|
R1507_Baseline Missing
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO) Includes all participants with missing fasting glucose at baseline
|
|---|---|---|---|---|
|
Percentage of Participants With Progression Free Survival (PFS)
Progression-Free & Alive
|
32.4 Percentage of participants
Interval 17.4 to 50.5
|
—
|
—
|
—
|
|
Percentage of Participants With Progression Free Survival (PFS)
Progressed, Died, or Unknown
|
67.6 Percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment to death; up to the time that all participants ended treatmentPopulation: All Treated Population
The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Patients were followed from start of therapy until date of first responsePopulation: All Treated Population
Objective response is defined as a complete response (CR) or partial response (PR) that has been confirmed by a second tumor assessment no earlier than 4 weeks after the initial documentation. Response is assessed using Response Evaluation Criteria in Solid Tumors (RECIST)criteria. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Patients were followed from start of therapy until date of first responsePopulation: All Treated Population
This is defined as time from the start of therapy to the date of first CR or PR. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of therapy to the date of first documentation of PD. Pts who never progress prior to final analysis or are withdrawn from the study without documented progression will be censored at the date of the last valid tumor assessment.Population: All Treated Population
The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from the date the complete or partial response was first recorded to the date which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be takenPopulation: All Treated Population
This is defined similarly for complete and partial responders. Complete response or partial response lasts from the date the complete response or partial response was first recorded to the date on which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline within 28 days of starting treatment (screening visit).Population: Safety Population
Standard safety monitoring includes baseline Electrocardiogram (ECG). The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Highest Post-Baseline value within the timeframe of post-baseline collection up to when patient discontinued (up to 59 weeks)Population: Safety Population: based on the total number of participants n = 34
A fasting glucose was required at baseline, and random non-fasting glucose testing was performed weekly for the first 6 weeks followed by day 1 of each 3 week treatment phase. The number of participants with the highest post-baseline fasting glucose level at any time point post baseline relative to the participant's baseline glucose level is reported.
Outcome measures
| Measure |
R1507
n=26 Participants
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
|
R1507_Baseline Impaired Fasting Glucose
n=4 Participants
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
Includes all participants with a fasting glucose at baseline ≥ 110 to \< 126 mg/dL
|
R1507_Baseline Diabetes Mellitus
n=2 Participants
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
Includes all participants with a fasting glucose at baseline ≥ 126 mg/dL
|
R1507_Baseline Missing
n=2 Participants
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO) Includes all participants with missing fasting glucose at baseline
|
|---|---|---|---|---|
|
Fasting Glucose, Highest Post-Baseline Value
Normal (< 140 mg/dL)
|
21 participants
|
3 participants
|
1 participants
|
0 participants
|
|
Fasting Glucose, Highest Post-Baseline Value
Impaired Fasting Glucose (≥ 140 to ≤ 200 mg/dL)
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Fasting Glucose, Highest Post-Baseline Value
Diabetes Mellitus (> 200 mg/dL)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Fasting Glucose, Highest Post-Baseline Value
Missing
|
3 participants
|
0 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: screeningPopulation: Safety Population
Standard safety monitoring includes baseline Electrocardiogram (ECG), Fasting glucose and HbA1c, monthly urine pregnancy test in female patients of childbearing potential and Human anti-human antibody (HAHA) testing. Data will be represented in the Serious Adverse Event (SAE) Adverse Event (AE) section of Protocol Registration System (PRS).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days of starting treatment (baseline visit)Population: Female patients of childbearing potential
Standard safety monitoring includes baseline Electrocardiogram (ECG), Fasting glucose and HbA1c, monthly urine pregnancy test in female patients of childbearing potential and Human anti-human antibody (HAHA) testing. Not posted; it will be represented in the Serious Adverse Event (SAE) Adverse Event (AE) section of Protocol Registration System (PRS).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: prior to dosing on week 1 (day 1), week 4 (day 22), week 10 (day 64), final visit, follow up visit and 12 weeks post last dose (up to 71 weeks)Population: Safety Population
Number of participants who tested positive for Human anti-human antibody (HAHA) testing for immunogenicity. To determine HAHA specificity, screened positive samples were tested in a confirmatory assay in the presence of 10 ug/mL R1507. Samples with \> 19.7% inhibition were considered true positives, whereas those with \< 19.7% inhibition were considered to be false positives.
Outcome measures
| Measure |
R1507
n=6 Participants
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
|
R1507_Baseline Impaired Fasting Glucose
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
Includes all participants with a fasting glucose at baseline ≥ 110 to \< 126 mg/dL
|
R1507_Baseline Diabetes Mellitus
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
Includes all participants with a fasting glucose at baseline ≥ 126 mg/dL
|
R1507_Baseline Missing
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO) Includes all participants with missing fasting glucose at baseline
|
|---|---|---|---|---|
|
Number of Participants With Positive Results for Human Anti-human Antibody (HAHA) Testing
POSITIVE
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Positive Results for Human Anti-human Antibody (HAHA) Testing
FALSE POSITIVE
|
5 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and thereafter as clinically indicated at the discretion of the investigator up to the time that the patient discontinued (up to 59 weeks)Population: Safety Population
12 lead ECG is required at baseline and will be measured during the trial as clinically indicated at the discretion of the investigators. For each reading, QTcF value will be calculated as the QT value (seconds) divided by the cube root of the RR interval in seconds (Fridericia correction). A listing will be generated showing, for each patient, the visits at which ECGs were taken and the results (normal or abnormal, as well as any comments provided).
Outcome measures
| Measure |
R1507
n=34 Participants
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
|
R1507_Baseline Impaired Fasting Glucose
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
Includes all participants with a fasting glucose at baseline ≥ 110 to \< 126 mg/dL
|
R1507_Baseline Diabetes Mellitus
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
Includes all participants with a fasting glucose at baseline ≥ 126 mg/dL
|
R1507_Baseline Missing
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO) Includes all participants with missing fasting glucose at baseline
|
|---|---|---|---|---|
|
Electrocardiogram (ECG)
Summary of QTcF Interval (n = 2)
|
421.5 ms (millisecond)
Standard Deviation 3.54
|
—
|
—
|
—
|
|
Electrocardiogram (ECG)
Change from Baseline (n = 1)
|
24.0 ms (millisecond)
Standard Deviation NA
only one participant evaluated; standard deviation was not calculated
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Throughout studyPopulation: Population PK of R1507 and erlotinib
Population PK of R1507 and erlotinib were planned but not analyzed due to the termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Throughout studyPopulation: Responders and non-responders
Total IGF-I, free IGF I/II and other potential biomarkers present in serum. Further putative biomarker analyses in blood and tumor samples were planned in the protocol for exploratory assessment of correlation with clinical outcome. None of these were analyzed due to the termination of the trial.
Outcome measures
Outcome data not reported
Adverse Events
R1507
Serious adverse events
| Measure |
R1507
n=34 participants at risk
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
|
|---|---|
|
General disorders
ASTHENIA
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
General disorders
MUCOSAL INFLAMMATION
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
General disorders
PAIN
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Nervous system disorders
CONVULSION
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Nervous system disorders
EPILEPSY
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Blood and lymphatic system disorders
THROMBOTIC MICROANGIOPATHY
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Infections and infestations
PNEUMONIA
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Reproductive system and breast disorders
PROSTATITIS
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
2.9%
1/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
Other adverse events
| Measure |
R1507
n=34 participants at risk
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
|
|---|---|
|
General disorders
ASTHENIA
|
52.9%
18/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
General disorders
DECREASED APPETITE
|
44.1%
15/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Gastrointestinal disorders
DIARRHOEA
|
44.1%
15/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
26.5%
9/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
26.5%
9/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Gastrointestinal disorders
VOMITING
|
20.6%
7/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Gastrointestinal disorders
NAUSEA
|
17.6%
6/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Skin and subcutaneous tissue disorders
RASH
|
17.6%
6/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Skin and subcutaneous tissue disorders
NAIL TOXICITY
|
14.7%
5/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Skin and subcutaneous tissue disorders
SKIN TOXICITY
|
14.7%
5/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Gastrointestinal disorders
CONSTIPATION
|
11.8%
4/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
11.8%
4/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
8.8%
3/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
8.8%
3/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
8.8%
3/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS
|
8.8%
3/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Eye disorders
CONJUNCTIVITIS
|
8.8%
3/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Psychiatric disorders
DEPRESSION
|
8.8%
3/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Blood and lymphatic system disorders
EPISTAXIS
|
8.8%
3/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Nervous system disorders
MYALGIA
|
8.8%
3/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
General disorders
NECK PAIN
|
8.8%
3/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
General disorders
PARONYCHIA
|
8.8%
3/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
8.8%
3/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Skin and subcutaneous tissue disorders
ACNE
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Metabolism and nutrition disorders
BLOOD MAGNESIUM DECREASED
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
General disorders
CHEST PAIN
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
General disorders
DYSGEUSIA
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
General disorders
DYSPHONIA
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Nervous system disorders
FATIGUE
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Blood and lymphatic system disorders
HAEMOPTYSIS
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
General disorders
HEADACHE
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Vascular disorders
HYPERTENSION
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Gastrointestinal disorders
MUCOSAL INFLAMMATION
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DRYNESS
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Respiratory, thoracic and mediastinal disorders
PRESYNCOPE
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
General disorders
PYREXIA
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Renal and urinary disorders
RENAL FAILURE
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Skin and subcutaneous tissue disorders
SKIN REACTION
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Psychiatric disorders
SOMNOLENCE
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
Ear and labyrinth disorders
VERTIGO
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
|
General disorders
WEIGHT DECREASED
|
5.9%
2/34 • From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
|
Additional Information
Medical Communications
Hoffman-LaRoche
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER