Trial Outcomes & Findings for Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours. (NCT NCT00998296)
NCT ID: NCT00998296
Last Updated: 2015-08-19
Results Overview
Maximum tolerated dose (MTD) of nintedanib and afatinib based on the Percentage of participants experienced dose limiting toxicities during the dose escalation phase.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
70 participants
Primary outcome timeframe
first treatment cycle, up to 28 days
Results posted on
2015-08-19
Participant Flow
Trial consisted of a dose-escalation phase (to determine the maximum tolerated dose (MTD) of treatments administered concomitantly) and an expansion phase(to assess the safety and the preliminary anti-tumour activity of the combination therapy at the previously determined MTD in patients with non-small cell lung cancer or pancreatic adenocarcinoma)
Participant milestones
| Measure |
Nintedanib 150 mg +Afatinib 30 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 10 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 20 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
NSCLC
Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
Pancreatic Adenocarcinoma
Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
3
|
3
|
8
|
3
|
7
|
6
|
6
|
18
|
7
|
|
Overall Study
COMPLETED
|
6
|
2
|
3
|
3
|
6
|
3
|
6
|
4
|
4
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
2
|
0
|
1
|
2
|
2
|
18
|
7
|
Reasons for withdrawal
| Measure |
Nintedanib 150 mg +Afatinib 30 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 10 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 20 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
NSCLC
Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
Pancreatic Adenocarcinoma
Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive disease
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
14
|
5
|
|
Overall Study
Dose limiting or dose reducing toxicity
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
2
|
0
|
0
|
|
Overall Study
Other adverse event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Overall Study
Refused to continue taking trial med.
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Reason other than those specified above
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.
Baseline characteristics by cohort
| Measure |
Nintedanib 150 mg +Afatinib 30 mg - Continuously
n=6 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 10 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 20 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Continuously
n=8 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Intermittently
n=7 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Intermittently
n=6 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Intermittently
n=6 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
NSCLC
n=18 Participants
Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
Pancreatic Adenocarcinoma
n=7 Participants
Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
51.5 years
STANDARD_DEVIATION 9.7 • n=21 Participants
|
44.3 years
STANDARD_DEVIATION 8.1 • n=8 Participants
|
64.9 years
STANDARD_DEVIATION 3.5 • n=8 Participants
|
52.2 years
STANDARD_DEVIATION 6.0 • n=24 Participants
|
63.3 years
STANDARD_DEVIATION 10.3 • n=42 Participants
|
58.1 years
STANDARD_DEVIATION 10.9 • n=42 Participants
|
58.1 years
STANDARD_DEVIATION 6.8 • n=42 Participants
|
56.0 years
STANDARD_DEVIATION 9.7 • n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: first treatment cycle, up to 28 daysPopulation: TS
Maximum tolerated dose (MTD) of nintedanib and afatinib based on the Percentage of participants experienced dose limiting toxicities during the dose escalation phase.
Outcome measures
| Measure |
Nintedanib 150 mg +Afatinib 30 mg - Continuously
n=6 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 10 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 20 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Continuously
n=8 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Intermittently
n=7 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Intermittently
n=6 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Intermittently
n=6 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
NSCLC
Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
Pancreatic Adenocarcinoma
Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities
Alanine aminotransferase increased
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
|
Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities
Aspartate aminotransferase increased
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
|
Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities
Blood creatinine increased
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
|
Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities
Dehydration
|
0.0 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
—
|
—
|
|
Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities
Diarrhoea
|
0.0 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
25.0 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
|
Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities
Hepatocellular injury
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
|
Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities
Renal failure acute
|
0.0 percentage of participants
|
66.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
|
Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities
Hepatotoxicity
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: TS
The investigator evaluated whether complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) occurred in a patient. CR for target lesions: Disappearance of all target lesions. CR for non-target lesions: Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10mm short axis). PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study. PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions
Outcome measures
| Measure |
Nintedanib 150 mg +Afatinib 30 mg - Continuously
n=6 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 10 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 20 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Continuously
n=7 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Intermittently
n=6 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Intermittently
n=6 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Intermittently
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
NSCLC
n=17 Participants
Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
Pancreatic Adenocarcinoma
n=6 Participants
Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Tumour Response Rate Assessed by the Investigator According to the Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1
Complete response
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Overall Tumour Response Rate Assessed by the Investigator According to the Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1
Partial response
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
17.6 percentage of participants
|
0.0 percentage of participants
|
|
Overall Tumour Response Rate Assessed by the Investigator According to the Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1
Stable disease
|
66.7 percentage of participants
|
66.7 percentage of participants
|
66.7 percentage of participants
|
33.3 percentage of participants
|
71.4 percentage of participants
|
100 percentage of participants
|
66.7 percentage of participants
|
83.3 percentage of participants
|
100.0 percentage of participants
|
70.6 percentage of participants
|
33.3 percentage of participants
|
|
Overall Tumour Response Rate Assessed by the Investigator According to the Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1
Progressive disease
|
33.3 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
66.7 percentage of participants
|
28.6 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
11.8 percentage of participants
|
66.6 percentage of participants
|
SECONDARY outcome
Timeframe: First treatment administration until cut-off date of 02Oct2014; up to 336 daysPopulation: TS
Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).
Outcome measures
| Measure |
Nintedanib 150 mg +Afatinib 30 mg - Continuously
n=6 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 10 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 20 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Continuously
n=8 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Intermittently
n=7 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Intermittently
n=6 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Intermittently
n=6 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
NSCLC
n=18 Participants
Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
Pancreatic Adenocarcinoma
n=7 Participants
Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence and Intensity of Adverse Events According to CTCAE (Common Toxicity Criteria Adverse Event) Version 3.0
CTCAE Grade 1
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence and Intensity of Adverse Events According to CTCAE (Common Toxicity Criteria Adverse Event) Version 3.0
CTCAE Grade 2
|
2 participants
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
2 participants
|
4 participants
|
0 participants
|
7 participants
|
2 participants
|
|
Incidence and Intensity of Adverse Events According to CTCAE (Common Toxicity Criteria Adverse Event) Version 3.0
CTCAE Grade 3
|
1 participants
|
2 participants
|
2 participants
|
1 participants
|
5 participants
|
2 participants
|
4 participants
|
2 participants
|
3 participants
|
7 participants
|
2 participants
|
|
Incidence and Intensity of Adverse Events According to CTCAE (Common Toxicity Criteria Adverse Event) Version 3.0
CTCAE Grade 4
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
2 participants
|
|
Incidence and Intensity of Adverse Events According to CTCAE (Common Toxicity Criteria Adverse Event) Version 3.0
CTCAE Grade 5
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: First treatment administration until cut-off date of 02 October 2014, up to 336 daysPopulation: TS
Changes in safety laboratory Parameters reported as adverse events
Outcome measures
| Measure |
Nintedanib 150 mg +Afatinib 30 mg - Continuously
n=6 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 10 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 20 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Continuously
n=8 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Continuously
n=3 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Intermittently
n=7 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Intermittently
n=6 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Intermittently
n=6 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
NSCLC
n=18 Participants
Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
Pancreatic Adenocarcinoma
n=7 Participants
Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Changes in Safety Laboratory Parameters
Alanine aminotransferase increased
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
3 participants
|
3 participants
|
1 participants
|
3 participants
|
3 participants
|
1 participants
|
1 participants
|
|
Changes in Safety Laboratory Parameters
Aspartate aminotransferase increased
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
3 participants
|
3 participants
|
1 participants
|
2 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Changes in Safety Laboratory Parameters
Blood creatinine increased
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Changes in Safety Laboratory Parameters
Blood alkaline phosphatase increased
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Changes in Safety Laboratory Parameters
Blood bilirubin increased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Changes in Safety Laboratory Parameters
Troponin increased
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Changes in Safety Laboratory Parameters
Gamma-glutamyltransferase increased
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
4 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Changes in Safety Laboratory Parameters
Blood creatinine phosphokinase increased
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Changes in Safety Laboratory Parameters
Blood fibrinogen increased
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Changes in Safety Laboratory Parameters
Hepatic enzymes increased
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 22 and Day 28Population: PKS. Only 6 patients were planned to be treated in the "Nintedanib 150 mg +Afatinib 30 mg- Continuously" group. Nevertheless, the patients were allowed to reduce their dose and by the way they changed the group and came in the "Nintedanib 150 mg +Afatinib 30 mg- Continuously" group with at the end N = 8 evaluable concentrations instead of 6 planned
Cpre,ss,norm (Dose normalized trough plasma concentration of nintedanib at steady state) are presented for the 2 MTD treatment groups (continuous administered nintedanib at 150 mg b.i.d. concomitantly with continuously administered afatinib 30 mg q.d. or with intermittently administered afatinib 40 mg q.d.) As nintedanib is given twice daily, samples are taken at Day 8, Day 15, Day 22 and Day 28; the Pharmacokinetic (PK) parameter names will be Cpre,ss,15,norm (Day 8), Cpre,ss,29,norm (Day 15), Cpre,ss,43,norm (Day 22) and Cpre,ss,55,norm (Day 28)
Outcome measures
| Measure |
Nintedanib 150 mg +Afatinib 30 mg - Continuously
n=8 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Continuously
n=7 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 10 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 20 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
NSCLC
Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
Pancreatic Adenocarcinoma
Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cpre,ss,Norm (Dose Normalized Trough Plasma Concentration of Nintedanib at Steady State)
Cpre,ss,29,norm (N= 6, 6)
|
0.0948 nanogram/millilitre/milligram (ng/mL/mg)
Geometric Coefficient of Variation 136
|
0.0755 nanogram/millilitre/milligram (ng/mL/mg)
Geometric Coefficient of Variation 148
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cpre,ss,Norm (Dose Normalized Trough Plasma Concentration of Nintedanib at Steady State)
Cpre,ss,43,norm (N= 5, 6)
|
0.112 nanogram/millilitre/milligram (ng/mL/mg)
Geometric Coefficient of Variation 125
|
0.0762 nanogram/millilitre/milligram (ng/mL/mg)
Geometric Coefficient of Variation 79.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cpre,ss,Norm (Dose Normalized Trough Plasma Concentration of Nintedanib at Steady State)
Cpre,ss,15,norm (N= 6, 7)
|
0.122 nanogram/millilitre/milligram (ng/mL/mg)
Geometric Coefficient of Variation 155
|
0.0731 nanogram/millilitre/milligram (ng/mL/mg)
Geometric Coefficient of Variation 92.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cpre,ss,Norm (Dose Normalized Trough Plasma Concentration of Nintedanib at Steady State)
Cpre,ss,55,norm (N= 8, NA)
|
0.0797 nanogram/millilitre/milligram (ng/mL/mg)
Geometric Coefficient of Variation 247
|
NA nanogram/millilitre/milligram (ng/mL/mg)
Geometric Coefficient of Variation NA
Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7, Day 13, Day 15, Day 22, Day 27 and Day 28Population: PKS. Only 6 patients were planned to be treated in the "Nintedanib 150 mg +Afatinib 30 mg- Continuously" group. Nevertheless, the patients were allowed to reduce their dose and by the way they changed the group and came in the "Nintedanib 150 mg +Afatinib 30 mg- Continuously" group with at the end N = 8 evaluable concentrations instead of 6 planned
C(pre,ss) is defined as pre-dose (trough) concentration of afatinib in plasma at steady state immediately before administration of the next dose. C24,7 corresponds to the plasma concentration at 24 hours on Day 7. C24,13 corresponds to the plasma concentration at 24 hours on Day 13. C24,27 corresponds to the plasma concentration at 24 hours on Day 27.
Outcome measures
| Measure |
Nintedanib 150 mg +Afatinib 30 mg - Continuously
n=8 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Continuously
n=7 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 10 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 20 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
NSCLC
Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
Pancreatic Adenocarcinoma
Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Plasma Concentration of Afatinib at Steady State
C24,27 (N= NA, 2)
|
NA nanogram/millilitre (ng/mL)
Geometric Coefficient of Variation NA
Not applicable (Value not calculated): C24,27 was calculated for the intermittent treatment; So, not available for the first treatment because no blood was taken at this time
|
30.5 nanogram/millilitre (ng/mL)
Geometric Coefficient of Variation 21.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentration of Afatinib at Steady State
Cpre,ss,15 (N= 6, NA)
|
15.5 nanogram/millilitre (ng/mL)
Geometric Coefficient of Variation 62.0
|
NA nanogram/millilitre (ng/mL)
Geometric Coefficient of Variation NA
Not applicable (Value not calculated): Cpre,ss,15 was calculated for the intermittent treatment because the values were not available. No blood was taken at this time
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentration of Afatinib at Steady State
Cpre,ss,22 (N= 6, NA)
|
19.0 nanogram/millilitre (ng/mL)
Geometric Coefficient of Variation 56.5
|
NA nanogram/millilitre (ng/mL)
Geometric Coefficient of Variation NA
Not applicable (Value not calculated): Cpre,ss,22 was calculated for the intermittent treatment because the values were not available. No blood was taken at this time
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentration of Afatinib at Steady State
Cpre,ss,28 (N= 8, NA)
|
19.1 nanogram/millilitre (ng/mL)
Geometric Coefficient of Variation 63.3
|
NA nanogram/millilitre (ng/mL)
Geometric Coefficient of Variation NA
Not applicable (Value not calculated): Cpre,ss,28 was calculated for the intermittent treatment because the values were not available. No blood was taken at this time
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentration of Afatinib at Steady State
C24,7 (N= NA, 6)
|
NA nanogram/millilitre (ng/mL)
Geometric Coefficient of Variation NA
Not applicable (Value not calculated): C24,7 was calculated for the intermittent treatment; So, not available for the first treatment because no blood was taken at this time
|
19.6 nanogram/millilitre (ng/mL)
Geometric Coefficient of Variation 127.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentration of Afatinib at Steady State
C24,13 (N= NA, 5)
|
NA nanogram/millilitre (ng/mL)
Geometric Coefficient of Variation NA
Not applicable (Value not calculated): C24,13 was calculated for the intermittent treatment; So, not available for the first treatment because no blood was taken at this time
|
11.5 nanogram/millilitre (ng/mL)
Geometric Coefficient of Variation 76.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)Population: Treated set
OR is defined as a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1, CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions. All lymph nodes must be nonpathological in size (\<10mm short axis). PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Other factors which add to the overall response of an imaging timepoint as PR are as below: CR in TL, but non-CR/Non-PD in NTL leads to PR CR in TL, but not evaluated NTL leads to PR PR in TL, but non-PD NTL or not all evaluated NTL leads to PR; All the above scenarios should also satisfy 'No occurrence of new lesions'.
Outcome measures
| Measure |
Nintedanib 150 mg +Afatinib 30 mg - Continuously
n=18 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Continuously
n=7 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 10 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 20 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
NSCLC
Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
Pancreatic Adenocarcinoma
Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response (OR) During the Expansion Phase
Yes
|
22.2 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Objective Response (OR) During the Expansion Phase
No
|
72.2 percentage of participants
|
85.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Objective Response (OR) During the Expansion Phase
Missing
|
5.6 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)Population: Treated set
DC is defined as the best overall response of CR, PR, stable disease (SD) and non-CR/non-PD. CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions . All lymph nodes must be non-pathological in size (\<10mm short axis). PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Other factors which add to the overall response of an imaging timepoint as PR are as below:- CR in TL, but non-CR/Non-PD in NTL leads to PR CR in TL, but not evaluated NTL leads to PR PR in TL, but non-PD NTL or not all evaluated NTL leads to PR; SD for TL: change in the sum of diameters does not satisfy PR or PD. SD in TL, non-PD in NTL lead to overall response of SD, provided there is no appearance of new lesions.
Outcome measures
| Measure |
Nintedanib 150 mg +Afatinib 30 mg - Continuously
n=18 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Continuously
n=7 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 10 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 20 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
NSCLC
Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
Pancreatic Adenocarcinoma
Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Disease Control (DC) During the Expansion Phase
Yes
|
83.3 percentage of participants
|
28.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Disease Control (DC) During the Expansion Phase
No
|
11.1 percentage of participants
|
57.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Disease Control (DC) During the Expansion Phase
Missing
|
5.6 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)Population: Treated set
SD: Neither sufficient shrinkage to qualify for PR (Partial response) nor sufficient increase to qualify for PD(Progressive disease), taking as references the smallest sum of diameters SoD while on study. PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters. PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions.
Outcome measures
| Measure |
Nintedanib 150 mg +Afatinib 30 mg - Continuously
n=18 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Continuously
n=7 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 10 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 20 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
NSCLC
Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
Pancreatic Adenocarcinoma
Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stable Disease for at Least 12 Weeks During the Expansion Phase
Yes
|
44.4 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stable Disease for at Least 12 Weeks During the Expansion Phase
No
|
50.0 percentage of participants
|
85.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stable Disease for at Least 12 Weeks During the Expansion Phase
Missing
|
5.6 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)Population: Treated set
Percentage change in the tumour size from baseline is expressed as Number of subjects with maximum decrease from baseline in the sum of longest diameters of target lesions.
Outcome measures
| Measure |
Nintedanib 150 mg +Afatinib 30 mg - Continuously
n=16 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Continuously
n=6 Participants
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 10 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 20 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Continuously
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the "dose-escalation phase".
|
Nintedanib 150 mg +Afatinib 40 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 30 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
Nintedanib 200 mg +Afatinib 40 mg - Intermittently
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the "dose-escalation phase".
|
NSCLC
Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
Pancreatic Adenocarcinoma
Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in the Tumour Size From Baseline During the Expansion Phase
>=20%
|
1 participants
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage Change in the Tumour Size From Baseline During the Expansion Phase
>=0% and <20%
|
4 participants
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage Change in the Tumour Size From Baseline During the Expansion Phase
>-30% and <0%
|
6 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage Change in the Tumour Size From Baseline During the Expansion Phase
<-30%
|
5 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Nintedanib 150 mg +Afatinib 30 mg - Continuously
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Nintedanib 150 mg +Afatinib 40 mg - Continuously
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Nintedanib 200 mg +Afatinib 10 mg - Continuously
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Nintedanib 200 mg +Afatinib 20 mg - Continuosly
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Nintedanib 200 mg +Afatinib 30 mg - Continuously
Serious events: 7 serious events
Other events: 8 other events
Deaths: 0 deaths
Nintedanib 200 mg +Afatinib 40 mg - Continuously
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Nintedanib 150 mg +Afatinib 40 mg - Intermittently
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Nintedanib 200 mg +Afatinib 30 mg - Intermittently
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Nintedanib 200 mg +Afatinib 40 mg - Intermittently
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
NSCLC
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Pancreatic Adenocarcinoma
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nintedanib 150 mg +Afatinib 30 mg - Continuously
n=6 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given continuously once daily (q.d.)
|
Nintedanib 150 mg +Afatinib 40 mg - Continuously
n=3 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given continuously once daily (q.d.)
|
Nintedanib 200 mg +Afatinib 10 mg - Continuously
n=3 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 10 mg was given continuously once daily (q.d.)
|
Nintedanib 200 mg +Afatinib 20 mg - Continuosly
n=3 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 20 mg was given continuously once daily (q.d.)
|
Nintedanib 200 mg +Afatinib 30 mg - Continuously
n=8 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given continuously once daily (q.d.)
|
Nintedanib 200 mg +Afatinib 40 mg - Continuously
n=3 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given continuously once daily (q.d.)
|
Nintedanib 150 mg +Afatinib 40 mg - Intermittently
n=7 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week
|
Nintedanib 200 mg +Afatinib 30 mg - Intermittently
n=6 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week
|
Nintedanib 200 mg +Afatinib 40 mg - Intermittently
n=6 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week
|
NSCLC
n=18 participants at risk
Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
Pancreatic Adenocarcinoma
n=7 participants at risk
Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d) plus film-coated tablet of Afatinib 30 mg (q.d)). This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
37.5%
3/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
11.1%
2/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Asthenia
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
General physical health deterioration
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Hyperthermia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Pain
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Pyrexia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Hepatobiliary disorders
Hepatocellular injury
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Pneumonia pneumococcal
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
11.1%
2/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to ovary
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Renal and urinary disorders
Renal failure
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Surgical and medical procedures
Oesophageal operation
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
Other adverse events
| Measure |
Nintedanib 150 mg +Afatinib 30 mg - Continuously
n=6 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given continuously once daily (q.d.)
|
Nintedanib 150 mg +Afatinib 40 mg - Continuously
n=3 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given continuously once daily (q.d.)
|
Nintedanib 200 mg +Afatinib 10 mg - Continuously
n=3 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 10 mg was given continuously once daily (q.d.)
|
Nintedanib 200 mg +Afatinib 20 mg - Continuosly
n=3 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 20 mg was given continuously once daily (q.d.)
|
Nintedanib 200 mg +Afatinib 30 mg - Continuously
n=8 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given continuously once daily (q.d.)
|
Nintedanib 200 mg +Afatinib 40 mg - Continuously
n=3 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given continuously once daily (q.d.)
|
Nintedanib 150 mg +Afatinib 40 mg - Intermittently
n=7 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week
|
Nintedanib 200 mg +Afatinib 30 mg - Intermittently
n=6 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week
|
Nintedanib 200 mg +Afatinib 40 mg - Intermittently
n=6 participants at risk
Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week
|
NSCLC
n=18 participants at risk
Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
Pancreatic Adenocarcinoma
n=7 participants at risk
Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d) plus film-coated tablet of Afatinib 30 mg (q.d)). This is a part of the "expansion phase" which follows on the dose-escalation phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
11.1%
2/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Melaena
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
50.0%
4/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
57.1%
4/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
50.0%
3/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
83.3%
5/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
12/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
42.9%
3/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Eye disorders
Blepharitis
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Eye disorders
Visual acuity reduced
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
50.0%
4/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
22.2%
4/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
28.6%
2/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Abdominal pain lower
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Aerophagia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
28.6%
2/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
25.0%
2/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
28.6%
2/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
11.1%
2/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
6/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
8/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
85.7%
6/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
6/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
6/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
77.8%
14/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
85.7%
6/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
25.0%
2/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
28.6%
2/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
3/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
4/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
11.1%
2/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Haematemesis
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Tongue dry
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
62.5%
5/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
42.9%
3/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
83.3%
5/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
83.3%
5/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
6/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Asthenia
|
100.0%
6/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
8/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
71.4%
5/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
50.0%
3/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
72.2%
13/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
28.6%
2/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Axillary pain
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Chest pain
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Chills
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Face oedema
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Fatigue
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Feeling hot
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Inflammation
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Mucosal dryness
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Mucosal inflammation
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
50.0%
3/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
27.8%
5/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Oedema
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
11.1%
2/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Pain
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Pyrexia
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
25.0%
2/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Thirst
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
General disorders
Xerosis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
11.1%
2/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
4/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
11.1%
2/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Immune system disorders
Iodine allergy
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Candida infection
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Folliculitis
|
66.7%
4/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
50.0%
4/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
57.1%
4/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
50.0%
3/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Furuncle
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Infection
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Laryngitis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Paronychia
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Rash pustular
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Rhinitis
|
50.0%
3/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
50.0%
4/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
27.8%
5/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Skin infection
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Tracheitis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
25.0%
2/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
11.1%
2/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Injury, poisoning and procedural complications
Medication error
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Injury, poisoning and procedural complications
Periorbital haemorrhage
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
25.0%
2/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
50.0%
3/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
50.0%
3/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
25.0%
2/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
28.6%
2/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
28.6%
2/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
57.1%
4/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Investigations
Troponin increased
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Investigations
Weight decreased
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
25.0%
2/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
22.2%
4/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
3/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
37.5%
3/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
57.1%
4/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
6/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
4/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
61.1%
11/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
28.6%
2/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
28.6%
2/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
50.0%
3/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
28.6%
2/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
25.0%
2/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
28.6%
2/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
22.2%
4/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
27.8%
5/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
11.1%
2/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Musculoskeletal and connective tissue disorders
Clubbing
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
25.0%
2/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
28.6%
2/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
27.8%
5/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Nervous system disorders
Cervical root pain
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Nervous system disorders
Paraesthesia
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Nervous system disorders
Parosmia
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Psychiatric disorders
Confusional state
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
11.1%
2/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Psychiatric disorders
Expressive language disorder
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Psychiatric disorders
Irritability
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Psychiatric disorders
Libido disorder
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Psychiatric disorders
Psychomotor retardation
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
25.0%
2/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
25.0%
2/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
25.0%
2/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
11.1%
2/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Renal and urinary disorders
Urinary tract obstruction
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
37.5%
3/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
3/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
25.0%
2/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
3/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
42.9%
3/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
28.6%
2/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
22.2%
4/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
100.0%
3/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
62.5%
5/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
3/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
3/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
50.0%
4/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
42.9%
3/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
50.0%
3/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
27.8%
5/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Nail growth abnormal
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
50.0%
3/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
11.1%
2/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
66.7%
2/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
61.1%
11/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
57.1%
4/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Scab
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
37.5%
3/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
33.3%
2/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
62.5%
5/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
27.8%
5/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
11.1%
2/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
5.6%
1/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
14.3%
1/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
33.3%
1/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
16.7%
1/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
12.5%
1/8 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/3 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/6 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/18 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
0.00%
0/7 • First treatment administration until cut-off date of 02Oct2014; up to 336 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER