Trial Outcomes & Findings for A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer. (NCT NCT00518011)
NCT ID: NCT00518011
Last Updated: 2016-05-16
Results Overview
Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2016-05-16
Participant Flow
A total of 17 chemo-naïve participants with Non-Small Cell Lung Cancer (NSCLC) Stage IIIB with pleural effusion or stage IV and a Eastern Cooperative Oncology Group performance status 2 (PS 2) were recruited. The study was conducted from 24 August 2007 to 14 February 2009 at 14 Centers in Australia.
Total 17 participants were enrolled; however the data was available for 16 participants. One participant in the gemcitabine arm withdrew consent before receiving treatment.
Participant milestones
| Measure |
Gemcitabine
Participants received Gemcitabine 1000 milligram per meter square (mg/m\^2)/day, intravenously (IV) on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
Erlotinib + Gemcitabine
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
| Measure |
Gemcitabine
Participants received Gemcitabine 1000 milligram per meter square (mg/m\^2)/day, intravenously (IV) on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
Erlotinib + Gemcitabine
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Disease Progression
|
2
|
2
|
|
Overall Study
Other Reasons
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.
Baseline characteristics by cohort
| Measure |
Gemcitabine
n=9 Participants
Participants received Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
Erlotinib + Gemcitabine
n=8 Participants
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 12.94 • n=39 Participants
|
76.8 years
STANDARD_DEVIATION 4.17 • n=41 Participants
|
74.0 years
STANDARD_DEVIATION 9.92 • n=35 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Per protocol (PP) population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death.
Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.
Outcome measures
| Measure |
Gemcitabine
n=8 Participants
Participants received Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
Erlotinib + Gemcitabine
n=7 Participants
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
|---|---|---|
|
Progression Free Survival
|
23.3 Week
Interval 7.1 to 24.9
|
24.4 Week
Interval 6.9 to
Not evaluable due to insufficient follow-up time and / or insufficient number of events.
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death.
Objective response rate was defined as the percentage of participants who have any evidence of confirmed objective of complete response (CR) + partial response (PR), as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD.
Outcome measures
| Measure |
Gemcitabine
n=8 Participants
Participants received Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
Erlotinib + Gemcitabine
n=7 Participants
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
|---|---|---|
|
Objective Response Rate
|
0 Percentage of participants
|
28.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death.
Disease control rate was defined as the percentage of participants who have any evidence of confirmed objective CR or PR or Stable disease (SD) (where SD was maintained for 8 weeks), as assessed by the RECIST version 1.0 criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of the LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of the LD since the treatment started. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Gemcitabine
n=8 Participants
Participants received Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
Erlotinib + Gemcitabine
n=7 Participants
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
|---|---|---|
|
Disease Control Rate
|
50 Percentage of participants
|
85.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: PP population included all randomized participants received at least one dose of study medication and had at least one post baseline tumor assessment or record of death. Participants available at the time of evaluation of duration of response were included in the analysis.
Duration of response was defined as the interval between the date of CR or PR was first recorded to the date on which progressive disease was first noted or date of death.
Outcome measures
| Measure |
Gemcitabine
Participants received Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
Erlotinib + Gemcitabine
n=2 Participants
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
|---|---|---|
|
Duration of Response
|
—
|
16.3 Week
Standard Deviation NA
Not evaluable due to insufficient follow-up time and / or insufficient number of events.
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death
Overall survival was defined as the interval between the date of randomization to the date of death from any cause.
Outcome measures
| Measure |
Gemcitabine
n=8 Participants
Participants received Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
Erlotinib + Gemcitabine
n=7 Participants
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
|---|---|---|
|
Overall Survival
|
21.1 Week
Interval 7.6 to
Not evaluable due to insufficient follow-up time and / or insufficient number of events.
|
39.0 Week
Interval 6.9 to
Not evaluable due to insufficient follow-up time and / or insufficient number of events.
|
SECONDARY outcome
Timeframe: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)Population: Safety population included all participants who received at least one dose or infusion of study treatment and had a safety assessment performed at baseline.
Mean change in pulse rate from Baseline for each cycle calculated as Day 1 of each cycle value minus Baseline value
Outcome measures
| Measure |
Gemcitabine
n=8 Participants
Participants received Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
Erlotinib + Gemcitabine
n=8 Participants
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
|---|---|---|
|
Mean Change in Pulse Rate From Baseline
Cycle 1 (n=8, 8)
|
2.37 beats per minute
Standard Deviation 14.31
|
3.00 beats per minute
Standard Deviation 5.58
|
|
Mean Change in Pulse Rate From Baseline
Cycle 2 (n=7, 6)
|
3.00 beats per minute
Standard Deviation 12.19
|
-3.00 beats per minute
Standard Deviation 12.96
|
|
Mean Change in Pulse Rate From Baseline
Cycle 3 (n=4, 5)
|
2.75 beats per minute
Standard Deviation 13.14
|
-1.80 beats per minute
Standard Deviation 7.08
|
|
Mean Change in Pulse Rate From Baseline
Cycle 4 (n=1, 5)
|
18.00 beats per minute
Standard Deviation NA
Standard Deviation was not calculated as only single participant was present for this group.
|
1.80 beats per minute
Standard Deviation 15.33
|
|
Mean Change in Pulse Rate From Baseline
Cycle 5 (n=1, 3)
|
-6.00 beats per minute
Standard Deviation NA
Standard Deviation was not calculated as only single participant was present for this group.
|
-9.00 beats per minute
Standard Deviation 18.52
|
|
Mean Change in Pulse Rate From Baseline
Cycle 6 (n= 1, 2)
|
4.00 beats per minute
Standard Deviation NA
Standard Deviation was not calculated as only single participant was present for this group.
|
6.00 beats per minute
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)Population: Safety population included all participants who received at least one dose or infusion of study treatment and had a safety assessment performed at Baseline.
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded as vital parameters in this study. Mean change in SBP and DBP from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.
Outcome measures
| Measure |
Gemcitabine
n=8 Participants
Participants received Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
Erlotinib + Gemcitabine
n=8 Participants
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
|---|---|---|
|
Mean Change in Blood Pressure From Baseline
SBP at Cycle 4 (n=1, 5)
|
-18.00 mm Hg
Standard Deviation NA
Standard Deviation was not calculated as only single participant was present for this group.
|
-10.20 mm Hg
Standard Deviation 16.52
|
|
Mean Change in Blood Pressure From Baseline
SBP at Cycle 1 (n=8, 8)
|
3.00 mm Hg
Standard Deviation 6.34
|
-0.87 mm Hg
Standard Deviation 9.40
|
|
Mean Change in Blood Pressure From Baseline
DBP at Cycle 1 (n=8, 8)
|
-6.87 mm Hg
Standard Deviation 9.41
|
-5.37 mm Hg
Standard Deviation 12.21
|
|
Mean Change in Blood Pressure From Baseline
SBP at Cycle 2 (n=7, 6)
|
-4.85 mm Hg
Standard Deviation 8.33
|
-17.83 mm Hg
Standard Deviation 9.90
|
|
Mean Change in Blood Pressure From Baseline
DBP at Cycle 2 (n=7, 6)
|
-10.71 mm Hg
Standard Deviation 9.44
|
-9.50 mm Hg
Standard Deviation 11.81
|
|
Mean Change in Blood Pressure From Baseline
SBP at Cycle 3 (n=4, 5)
|
-9.00 mm Hg
Standard Deviation 8.67
|
-17.20 mm Hg
Standard Deviation 19.14
|
|
Mean Change in Blood Pressure From Baseline
DBP at Cycle 3 (n=4, 5)
|
-8.25 mm Hg
Standard Deviation 11.89
|
-9.20 mm Hg
Standard Deviation 15.64
|
|
Mean Change in Blood Pressure From Baseline
DBP at Cycle 4 (n=1, 5)
|
-4.00 mm Hg
Standard Deviation NA
Standard Deviation was not calculated as only single participant was present for this group.
|
-1.60 mm Hg
Standard Deviation 14.32
|
|
Mean Change in Blood Pressure From Baseline
SBP at Cycle 5 (n=1, 3)
|
28.00 mm Hg
Standard Deviation NA
Standard Deviation was not calculated as only single participant was present for this group.
|
-1.66 mm Hg
Standard Deviation 12.34
|
|
Mean Change in Blood Pressure From Baseline
DBP at Cycle 5 (n=1, 3)
|
12.00 mm Hg
Standard Deviation NA
Standard Deviation was not calculated as only single participant was present for this group.
|
0.66 mm Hg
Standard Deviation 2.51
|
|
Mean Change in Blood Pressure From Baseline
SBP at Cycle 6 (n=1, 2)
|
10.00 mm Hg
Standard Deviation NA
Standard Deviation was not calculated as only single participant was present for this group.
|
5.00 mm Hg
Standard Deviation 0.00
|
|
Mean Change in Blood Pressure From Baseline
DBP at Cycle 6 (n=1, 2)
|
5.00 mm Hg
Standard Deviation NA
Standard Deviation was not calculated as only single participant was present for this group.
|
-0.50 mm Hg
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)Population: Safety population included all participants who received at least one dose/infusion and had at least one safety assessment performed at baseline.
Mean change in body temperature from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.
Outcome measures
| Measure |
Gemcitabine
n=8 Participants
Participants received Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
Erlotinib + Gemcitabine
n=8 Participants
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
|---|---|---|
|
Mean Change in Body Temperature From Baseline
Cycle 1 (n=8, 8)
|
-0.02 Fahrenheit
Standard Deviation 0.73
|
-0.012 Fahrenheit
Standard Deviation 0.11
|
|
Mean Change in Body Temperature From Baseline
Cycle 2 (n=7, 6)
|
0.14 Fahrenheit
Standard Deviation 0.82
|
-0.30 Fahrenheit
Standard Deviation 0.40
|
|
Mean Change in Body Temperature From Baseline
Cycle 3 (n=4, 5)
|
-0.07 Fahrenheit
Standard Deviation 0.68
|
-0.32 Fahrenheit
Standard Deviation 0.37
|
|
Mean Change in Body Temperature From Baseline
Cycle 4 (n=1, 5)
|
-0.60 Fahrenheit
Standard Deviation NA
Standard Deviation was not calculated as only single participant was present for this group.
|
-0.24 Fahrenheit
Standard Deviation 0.46
|
|
Mean Change in Body Temperature From Baseline
Cycle 5 (n=1, 3)
|
-0.70 Fahrenheit
Standard Deviation NA
Standard Deviation was not calculated as only single participant was present for this group.
|
-0.46 Fahrenheit
Standard Deviation 0.25
|
|
Mean Change in Body Temperature From Baseline
Cycle 6 (n=1, 2)
|
-0.20 Fahrenheit
Standard Deviation NA
Standard Deviation was not calculated as only single participant was present for this group.
|
-0.20 Fahrenheit
Standard Deviation 0.98
|
Adverse Events
Gemcitabine
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Erlotinib + Gemcitabine
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine
n=8 participants at risk
Participants received Gemcitabine (1000 mg/m\^2/day), IV on Days 1, 8, 15 of each 4 week cycle for 6 cycles
|
Erlotinib + Gemcitabine
n=8 participants at risk
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Cellulitis
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Lower respiratory tract infection
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
Recall phenomenon
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
Cerebrovascular accident
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Oedema peripheral
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Pain
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
Other adverse events
| Measure |
Gemcitabine
n=8 participants at risk
Participants received Gemcitabine (1000 mg/m\^2/day), IV on Days 1, 8, 15 of each 4 week cycle for 6 cycles
|
Erlotinib + Gemcitabine
n=8 participants at risk
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
75.0%
6/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Nausea
|
37.5%
3/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
37.5%
3/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Constipation
|
37.5%
3/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
37.5%
3/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Lip dry
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
87.5%
7/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Fatigue
|
50.0%
4/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
50.0%
4/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Oedema peripheral
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Chills
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Feeling cold
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Influenza like illness
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Malaise
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Pain
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
Platelet count decreased
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
Weight decreased
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
Blood glucose fluctuation
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
Body temperature increased
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
50.0%
4/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
37.5%
3/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
Anorexia
|
37.5%
3/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
62.5%
5/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
Fluid overload
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Lower respiratory tract infection
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Paronychia
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Sinusitis
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
2/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
37.5%
3/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Eye disorders
Eye irritation
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Eye disorders
Blepharitis
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Eye disorders
Dry eye
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Eye disorders
Visual impairment
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Anxiety disorder
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Confusional state
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Panic attack
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
37.5%
3/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
Penile swelling
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebral hygroma
|
0.00%
0/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.5%
1/8 • Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 616878333
Email: [email protected]
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