Trial Outcomes & Findings for Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer (NCT NCT01325428)
NCT ID: NCT01325428
Last Updated: 2016-07-19
Results Overview
Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as \>182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
Results posted on
2016-07-19
Participant Flow
This was an open-label study conducted in two sequential parts (Part A in which patients were treated with Afatinib (BIBW 2992) as monotherapy; Part B in which patients were treated with Afatinib plus Vinorelbine as combination therapy after progression on Afatinib monotherapy).
Part A: Patients were treated with Afatinib and could continue on treatment until first Progression of Disease (PD), intolerable side effects, or withdrawal of consent. Upon first PD, patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with weekly Vinorelbine.
Participant milestones
| Measure |
Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B).
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related adverse events (AEs), the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent.
|
|---|---|
|
Part A
STARTED
|
26
|
|
Part A
COMPLETED
|
10
|
|
Part A
NOT COMPLETED
|
16
|
|
Part B
STARTED
|
10
|
|
Part B
COMPLETED
|
7
|
|
Part B
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B).
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related adverse events (AEs), the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent.
|
|---|---|
|
Part A
Progressive disease according to RECIST
|
9
|
|
Part A
Clinical signs, symptoms of progression
|
2
|
|
Part A
Other adverse event
|
1
|
|
Part A
Refused continue taking trial medication
|
2
|
|
Part A
Other reason not defined above
|
2
|
|
Part B
Refused continue taking trial medication
|
2
|
|
Part B
Other reason not defined above
|
1
|
Baseline Characteristics
Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
Baseline characteristics by cohort
| Measure |
Part A: Afatinib Once Daily. Part B: Afatinib+V (Vinorelbine).
n=26 Participants
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent.
|
|---|---|
|
Age, Customized
Part A
|
51.5 Years
STANDARD_DEVIATION 8.8 • n=93 Participants
|
|
Age, Customized
Part B
|
51.5 Years
STANDARD_DEVIATION 12.5 • n=93 Participants
|
|
Sex/Gender, Customized
Female (Part A)
|
26 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Female (Part B)
|
10 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Male (Part A)
|
0 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Male (Part B)
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.Population: TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.
Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as \>182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
Outcome measures
| Measure |
Part A: Afatinib Once Daily (OD).
n=26 Participants
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
The 95% Confidence Interval is Exact Confidence Interval.
|
|---|---|
|
Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
|
35 Percentage of participants
Interval 17.0 to 56.0
|
PRIMARY outcome
Timeframe: This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.Population: TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.
Tumour response was assessed separately for Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as \>182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
Outcome measures
| Measure |
Part A: Afatinib Once Daily (OD).
n=10 Participants
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
The 95% Confidence Interval is Exact Confidence Interval.
|
|---|---|
|
Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
|
20 Percentage of participants
Interval 3.0 to 56.0
|
SECONDARY outcome
Timeframe: This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.Population: TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.
Objective response was defined on a patient level as a best response of CR or PR.
Outcome measures
| Measure |
Part A: Afatinib Once Daily (OD).
n=26 Participants
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
The 95% Confidence Interval is Exact Confidence Interval.
|
|---|---|
|
Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
|
31 Percentage of participants
Interval 14.0 to 52.0
|
SECONDARY outcome
Timeframe: This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.Population: TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.
Objective response was defined on a patient level as a best response of CR or PR.
Outcome measures
| Measure |
Part A: Afatinib Once Daily (OD).
n=10 Participants
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
The 95% Confidence Interval is Exact Confidence Interval.
|
|---|---|
|
Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
|
10 Percentage of participants
Interval 0.0 to 45.0
|
SECONDARY outcome
Timeframe: This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.Population: TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.
Objective response was defined on a patient level as a best response of CR or PR.
Outcome measures
| Measure |
Part A: Afatinib Once Daily (OD).
n=26 Participants
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
The 95% Confidence Interval is Exact Confidence Interval.
|
|---|---|
|
Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
|
42 Percentage of participants
Interval 23.0 to 63.0
|
SECONDARY outcome
Timeframe: This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.Population: TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.
Objective response was defined on a patient level as a best response of CR or PR.
Outcome measures
| Measure |
Part A: Afatinib Once Daily (OD).
n=10 Participants
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
The 95% Confidence Interval is Exact Confidence Interval.
|
|---|---|
|
Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).
|
30 Percentage of participants
Interval 7.0 to 65.0
|
SECONDARY outcome
Timeframe: From first drug administration until end of Part A, up to 929 days.Population: TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.
Objective Response (OR) was defined on a patient level as a best response of Complete Response (CR) or Partial Response (PR). Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for Progression Free Survival (PFS)).
Outcome measures
| Measure |
Part A: Afatinib Once Daily (OD).
n=11 Participants
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
The 95% Confidence Interval is Exact Confidence Interval.
|
|---|---|
|
Part A: Duration of Unconfirmed Objective Response.
|
NA Days
Interval 57.0 to
The Kaplan Meier (KM) probability never falls to 0.5 therefore the median can't be estimated. Not Applicable (NA).
|
SECONDARY outcome
Timeframe: From first drug administration until end of Part B, up to 929 days.Population: TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.
Objective response was defined on a patient level as a best response of CR or PR. Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for PFS).
Outcome measures
| Measure |
Part A: Afatinib Once Daily (OD).
n=3 Participants
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
The 95% Confidence Interval is Exact Confidence Interval.
|
|---|---|
|
Part B: Duration of Unconfirmed Objective Response.
|
57 Days
Interval 56.0 to 140.0
|
SECONDARY outcome
Timeframe: From first drug administration until end of Part A, up to 713 days.Population: TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.
PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study A.
Outcome measures
| Measure |
Part A: Afatinib Once Daily (OD).
n=26 Participants
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
The 95% Confidence Interval is Exact Confidence Interval.
|
|---|---|
|
Part A: Progression Free Survival.
|
110.5 Days
Interval 58.0 to 386.0
|
SECONDARY outcome
Timeframe: From first drug administration until end of Part B, up to 230 days.Population: TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.
PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study B.
Outcome measures
| Measure |
Part A: Afatinib Once Daily (OD).
n=10 Participants
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
The 95% Confidence Interval is Exact Confidence Interval.
|
|---|---|
|
Part B: Progression Free Survival.
|
106.0 Days
Interval 36.0 to 190.0
|
SECONDARY outcome
Timeframe: From first drug administration until end of study, up to 700 days.Population: TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A. TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.
PD was evaluated according to the RECIST version 1.1. Number of days from the start of monotherapy to the date of second PD.
Outcome measures
| Measure |
Part A: Afatinib Once Daily (OD).
n=26 Participants
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
The 95% Confidence Interval is Exact Confidence Interval.
|
|---|---|
|
Progression Free Survival Over the Whole Sudy.
|
253.0 Days
Interval 166.0 to 713.0
|
Adverse Events
Part A: Afatinib Once Daily (OD).
Serious events: 12 serious events
Other events: 26 other events
Deaths: 0 deaths
Part B: Afatinib+V (Vinorelbine).
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Afatinib Once Daily (OD).
n=26 participants at risk
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
|
Part B: Afatinib+V (Vinorelbine).
n=10 participants at risk
Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.5%
3/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
3/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
General disorders
Asthenia
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
General disorders
Fatigue
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
General disorders
Pain
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Hepatobiliary disorders
Hepatic lesion
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Infections and infestations
Abscess limb
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Infections and infestations
Cellulitis
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Infections and infestations
Sepsis
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Injury, poisoning and procedural complications
Hepatic haematoma
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Injury, poisoning and procedural complications
Wound complication
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Nervous system disorders
Headache
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Renal and urinary disorders
Renal failure
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
Other adverse events
| Measure |
Part A: Afatinib Once Daily (OD).
n=26 participants at risk
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
|
Part B: Afatinib+V (Vinorelbine).
n=10 participants at risk
Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent.
|
|---|---|---|
|
General disorders
Fatigue
|
15.4%
4/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
50.0%
5/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
General disorders
Mucosal inflammation
|
38.5%
10/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
30.0%
3/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Blood and lymphatic system disorders
Anaemia
|
15.4%
4/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
50.0%
5/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
80.0%
8/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Eye disorders
Dry eye
|
11.5%
3/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Eye disorders
Panophthalmitis
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
20.0%
2/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
2/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Gastrointestinal disorders
Diarrhoea
|
88.5%
23/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
60.0%
6/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
2/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Gastrointestinal disorders
Nausea
|
26.9%
7/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
50.0%
5/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Gastrointestinal disorders
Stomatitis
|
11.5%
3/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Gastrointestinal disorders
Vomiting
|
26.9%
7/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
General disorders
Catheter site erythema
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
General disorders
Pyrexia
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
20.0%
2/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Infections and infestations
Cystitis
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Infections and infestations
Eye infection
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Infections and infestations
Paronychia
|
34.6%
9/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
2/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
20.0%
2/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Investigations
Alanine aminotransferase increased
|
15.4%
4/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Investigations
Aspartate aminotransferase increased
|
15.4%
4/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.7%
2/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Investigations
Weight decreased
|
26.9%
7/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
40.0%
4/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
38.5%
10/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
20.0%
2/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
19.2%
5/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.7%
2/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
20.0%
2/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Nervous system disorders
Dizziness
|
7.7%
2/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
30.0%
3/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Nervous system disorders
Headache
|
11.5%
3/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Nervous system disorders
Migraine
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Nervous system disorders
Neuropathy peripheral
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Reproductive system and breast disorders
Breast pain
|
7.7%
2/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
20.0%
2/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.4%
4/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
19.2%
5/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
2/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.5%
3/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Skin and subcutaneous tissue disorders
Fungating wound
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
11.5%
3/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
2/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Skin and subcutaneous tissue disorders
Rash
|
65.4%
17/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
7.7%
2/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
0.00%
0/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
|
Vascular disorders
Lymphoedema
|
3.8%
1/26 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
10.0%
1/10 • Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim (BI)
Phone: 1800-243-0127
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