Trial Outcomes & Findings for A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer (NCT NCT02694536)
NCT ID: NCT02694536
Last Updated: 2017-03-24
Results Overview
An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
80 participants
Primary outcome timeframe
Up to approximately 40 months (assessed continuously during treatment)
Results posted on
2017-03-24
Participant Flow
Participant milestones
| Measure |
Erlotinib + Gemcitabine
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 milligrams (mg) orally (PO) once daily. Gemcitabine was administered as 1000 milligrams per meter-squared (mg/m\^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
80
|
Reasons for withdrawal
| Measure |
Erlotinib + Gemcitabine
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 milligrams (mg) orally (PO) once daily. Gemcitabine was administered as 1000 milligrams per meter-squared (mg/m\^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
|
|---|---|
|
Overall Study
Progressive Disease
|
40
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Study Drug-Related Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Death
|
8
|
|
Overall Study
Other
|
22
|
Baseline Characteristics
A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Erlotinib + Gemcitabine
n=80 Participants
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m\^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
|
|---|---|
|
Age, Continuous
|
62.45 years
STANDARD_DEVIATION 10.299 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 40 months (assessed continuously during treatment)Population: Safety Population
An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported.
Outcome measures
| Measure |
Erlotinib + Gemcitabine
n=80 Participants
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m\^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
78.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study)Population: Safety Population. The "Number of Participants Analyzed" reflects the total number of participants who contributed to the endpoint. The number of responses for each questionnaire item combined across all assessments (n) is shown in the table.
The QLQ-C30 is a 30-item questionnaire that assesses physical (Questions 1-5), role (Questions 6-7), emotional (Questions 21-24), cognitive (Questions 20 and 25), and social (Questions 26-27) functional domains as well as global health status (Questions 29-30) and several symptoms including fatigue (Questions 10, 12, and 18), pain (Questions 9 and 19), nausea/vomiting (Questions 14-15), dyspnea (Question 8), appetite loss (Question 13), insomnia (Question 11), constipation/diarrhea (Questions 16-17), and financial difficulties (Question 28). Questions 1 to 28 were assessed on a 4-point scale from 1 ("no/not at all") to 4 ("very much") where higher scores represented worse symptoms. Questions 29 and 30 were assessed on a 7-point scale from 1 ("very poor") to 7 ("excellent") where higher scores represented better functioning. Item scores over the study period were averaged among all participants across all visits for which data were available.
Outcome measures
| Measure |
Erlotinib + Gemcitabine
n=80 Participants
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m\^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
|
|---|---|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q14: Felt nauseated (n=257)
|
1.48 units on a scale
Standard Deviation 0.679
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q1: Trouble in strenuous activities (n=256)
|
1.96 units on a scale
Standard Deviation 0.758
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q2: Trouble with long walk (n=259)
|
2.03 units on a scale
Standard Deviation 0.802
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q3: Trouble with short walk (n=258)
|
1.50 units on a scale
Standard Deviation 0.696
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q4: Need to say in bed or chair (n=255)
|
1.87 units on a scale
Standard Deviation 0.699
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q5: Need help in daily activities (n=259)
|
1.21 units on a scale
Standard Deviation 0.501
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q6: Limited in doing work/daily activities (n=257)
|
1.82 units on a scale
Standard Deviation 0.803
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q7: Limited in pursuing hobbies (n=255)
|
1.73 units on a scale
Standard Deviation 0.798
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q8: Short of breath (n=258)
|
1.38 units on a scale
Standard Deviation 0.608
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q9: Pain (n=257)
|
1.88 units on a scale
Standard Deviation 0.771
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q10: Need to rest (n=255)
|
2.05 units on a scale
Standard Deviation 0.697
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q11: Trouble sleeping (n=257)
|
1.74 units on a scale
Standard Deviation 0.699
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q12: Felt weak (n=255)
|
2.05 units on a scale
Standard Deviation 0.774
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q13: Lacked appetite (n=257)
|
1.70 units on a scale
Standard Deviation 0.730
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q15: Vomited (n=259)
|
1.10 units on a scale
Standard Deviation 0.414
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q16: Constipated (n=259)
|
1.51 units on a scale
Standard Deviation 0.723
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q17: Diarrhea (n=259)
|
1.27 units on a scale
Standard Deviation 0.496
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q18: Tired (n=255)
|
2.07 units on a scale
Standard Deviation 0.689
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q19: Pain interference with daily activity (n=256)
|
1.69 units on a scale
Standard Deviation 0.814
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q20: Difficulty concentrating (n=257)
|
1.49 units on a scale
Standard Deviation 0.638
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q21: Felt tense (n=256)
|
1.97 units on a scale
Standard Deviation 0.716
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q22: Worried (n=253)
|
2.10 units on a scale
Standard Deviation 0.773
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q23: Felt irritable (n=258)
|
1.75 units on a scale
Standard Deviation 0.707
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q24: Felt depressed (n=258)
|
1.67 units on a scale
Standard Deviation 0.658
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q25: Difficulty remembering things (n=257)
|
1.44 units on a scale
Standard Deviation 0.543
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q26: Interference with family life (n=257)
|
1.59 units on a scale
Standard Deviation 0.680
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q27: Interference with social activities (n=257)
|
1.62 units on a scale
Standard Deviation 0.772
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q28: Financial difficulties (n=258)
|
1.32 units on a scale
Standard Deviation 0.655
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q29: Overall health (n=255)
|
4.44 units on a scale
Standard Deviation 1.314
|
|
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Q30: Overall quality of life (n=255)
|
4.38 units on a scale
Standard Deviation 1.346
|
SECONDARY outcome
Timeframe: Up to approximately 40 months (assessed continuously through end of study)Population: Safety Population. The "Number of Participants Analyzed" reflects the number of participants who contributed to the endpoint.
The percentage of participants who died from any cause was reported to the nearest integer.
Outcome measures
| Measure |
Erlotinib + Gemcitabine
n=78 Participants
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m\^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
|
|---|---|
|
Percentage of Participants Who Died
|
73 percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 40 months (assessed continuously through end of study)Population: Safety Population. The "Number of Participants Analyzed" reflects the number of participants who contributed to the endpoint.
OS was defined as the time from start of treatment to time of death from any cause. Participants who had not died at the time of final analysis were censored at the date of last contact. OS was estimated by Kaplan-Meier methodology and expressed in months.
Outcome measures
| Measure |
Erlotinib + Gemcitabine
n=78 Participants
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m\^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
|
|---|---|
|
Overall Survival (OS)
|
7.49 months
Interval 5.42 to 9.04
|
SECONDARY outcome
Timeframe: Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)Population: Safety Population. The "Number of Participants Analyzed" reflects the number of participants who contributed to the endpoint.
Tumor assessments were performed using RECIST. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of longest diameters (LD) of target lesions in reference to smallest sum of LD on study. The percentage of participants who died or demonstrated disease progression was reported to the nearest integer.
Outcome measures
| Measure |
Erlotinib + Gemcitabine
n=78 Participants
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m\^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
|
|---|---|
|
Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)
|
88 percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)Population: Safety Population. The "Number of Participants Analyzed" reflects the number of participants who contributed to the endpoint.
Tumor assessments were performed using RECIST. PFS was defined as the time from treatment start to the time of death or disease progression. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum of LD on study. PFS was estimated by Kaplan-Meier methodology and expressed in months.
Outcome measures
| Measure |
Erlotinib + Gemcitabine
n=78 Participants
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m\^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
|
|---|---|
|
Progression-Free Survival (PFS) According to RECIST
|
4.864 months
Interval 3.484 to 5.85
|
Adverse Events
Erlotinib + Gemcitabine
Serious events: 35 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib + Gemcitabine
n=80 participants at risk
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m\^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Cardiac disorders
Cardiac arrest
|
2.5%
2/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
3/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Gastrointestinal disorders
Pancreatic carcinoma
|
2.5%
2/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Gastrointestinal disorders
Peritonitis
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
General disorders
Disease progression
|
7.5%
6/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
General disorders
General physical health deterioration
|
2.5%
2/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
General disorders
Ill-defined disorder
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
General disorders
Pyrexia
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Hepatobiliary disorders
Hepatic failure
|
2.5%
2/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Hepatobiliary disorders
Jaundice
|
3.8%
3/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Infections and infestations
Liver abscess
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Infections and infestations
Pneumonia
|
2.5%
2/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
3.8%
3/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.5%
2/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Surgical and medical procedures
Surgery
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Vascular disorders
Deep vein thrombosis
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Blood and lymphatic system disorders
Melaena
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Gastrointestinal disorders
Ileus
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
General disorders
Multi-organ failure
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
1/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
Other adverse events
| Measure |
Erlotinib + Gemcitabine
n=80 participants at risk
Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m\^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.2%
21/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
22.5%
18/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
17.5%
14/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.2%
9/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
5/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
4/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
General disorders
Pyrexia
|
15.0%
12/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
General disorders
Asthenia
|
5.0%
4/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
6.2%
5/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
5/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
5/80 • Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
|
Additional Information
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