Trial Outcomes & Findings for Cetuximab in Combination With S-1 and Cisplatin in Gastric Cancer (NCT NCT01388790)
NCT ID: NCT01388790
Last Updated: 2013-11-20
Results Overview
The best overall response rate is defined as the percentage of participants having achieved confirmed complete response plus partial response as the best overall response according to radiological assessments (based on Response Evaluation Criteria in Solid Tumors version 1.0 \[RECIST v 1.0\] criteria).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Evaluations were performed every 6 weeks until disease progression, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012)
Results posted on
2013-11-20
Participant Flow
First/last participant (informed consent): 29 June 2011/16 January 2012; Clinical data cut-off: 14 August 2012; Study completion: 13 May 2013.
Enrolled: 41 screened for eligibility; 1 excluded (non-fulfillment of inclusion or exclusion criteria) and 40 participants included in the study.
Participant milestones
| Measure |
Cetuximab Plus Cisplatin Plus S-1
Cetuximab once weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by subsequent 250 mg/m\^2 intravenous infusion), cisplatin (60 mg/m\^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m\^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Cetuximab Plus Cisplatin Plus S-1
Cetuximab once weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by subsequent 250 mg/m\^2 intravenous infusion), cisplatin (60 mg/m\^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m\^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Overall Study
Ongoing at data cut-off date
|
8
|
Baseline Characteristics
Cetuximab in Combination With S-1 and Cisplatin in Gastric Cancer
Baseline characteristics by cohort
| Measure |
Cetuximab Plus Cisplatin Plus S-1
n=40 Participants
Cetuximab once weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by subsequent 250 mg/m\^2 intravenous infusion), cisplatin (60 mg/m\^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m\^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Age Continuous
|
61.7 years
STANDARD_DEVIATION 10.09 • n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Evaluations were performed every 6 weeks until disease progression, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012)Population: ITT population included all participants who received at least one dose of study treatment.
The best overall response rate is defined as the percentage of participants having achieved confirmed complete response plus partial response as the best overall response according to radiological assessments (based on Response Evaluation Criteria in Solid Tumors version 1.0 \[RECIST v 1.0\] criteria).
Outcome measures
| Measure |
Cetuximab Plus Cisplatin Plus S-1
n=40 Participants
Cetuximab once weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by subsequent 250 mg/m\^2 intravenous infusion), cisplatin (60 mg/m\^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m\^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Best Overall Response (BOR) Rate - Independent Review Committee (IRC) Assessments
|
40 percentage of participants
Interval 24.9 to 56.7
|
SECONDARY outcome
Timeframe: Time from start of treatment to disease progression, death or last tumor assessment, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012)Population: ITT population included all participants who received at least one dose of study treatment.
The PFS time is defined as the duration from start of treatment until radiological progression (based on RECIST v 1.0 criteria) or death due to any cause within 60 days of the last tumor assessment or start of treatment. Participants without event are censored on the date of last tumor assessment.
Outcome measures
| Measure |
Cetuximab Plus Cisplatin Plus S-1
n=40 Participants
Cetuximab once weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by subsequent 250 mg/m\^2 intravenous infusion), cisplatin (60 mg/m\^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m\^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Median Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments
|
5.6 months
Interval 4.2 to 8.3
|
Adverse Events
Cetuximab Plus Cisplatin Plus S-1
Serious events: 15 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab Plus Cisplatin Plus S-1
n=40 participants at risk
Cetuximab once weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by subsequent 250 mg/m\^2 intravenous infusion), cisplatin (60 mg/m\^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m\^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
2.5%
1/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Pyrexia
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Electrocardiogram T wave inversion
|
2.5%
1/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.0%
6/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
2.5%
1/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Renal artery thrombosis
|
2.5%
1/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Embolism
|
2.5%
1/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Trousseau's syndrome
|
2.5%
1/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Ileus
|
2.5%
1/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Neutropenic infection
|
2.5%
1/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood bilirubin increased
|
2.5%
1/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.5%
1/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.5%
1/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Hydronephrosis
|
2.5%
1/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
Other adverse events
| Measure |
Cetuximab Plus Cisplatin Plus S-1
n=40 participants at risk
Cetuximab once weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by subsequent 250 mg/m\^2 intravenous infusion), cisplatin (60 mg/m\^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m\^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Dysgeusia
|
30.0%
12/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Dizziness
|
10.0%
4/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.5%
3/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Insomnia
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
37.5%
15/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
75.0%
30/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
52.5%
21/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
30.0%
12/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
30.0%
12/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.5%
11/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
17.5%
7/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
17.5%
7/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Acne
|
12.5%
5/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
5/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
5/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.5%
3/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.5%
3/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Congenital, familial and genetic disorders
Trichomegaly
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Eye disorders
Lacrimation increased
|
12.5%
5/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Stomatitis
|
65.0%
26/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Constipation
|
62.5%
25/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Diarrhoea
|
60.0%
24/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
20/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
6/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Cheilitis
|
12.5%
5/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
4/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.5%
3/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Fatigue
|
47.5%
19/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Oedema peripheral
|
27.5%
11/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Pyrexia
|
25.0%
10/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Influenza like illness
|
10.0%
4/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Paronychia
|
52.5%
21/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Infection
|
10.0%
4/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
3/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Folliculitis
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
4/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Weight decreased
|
42.5%
17/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Neutrophil count decreased
|
25.0%
10/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Haemoglobin decreased
|
22.5%
9/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood creatinine increased
|
17.5%
7/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Weight increased
|
17.5%
7/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
White blood cell count decreased
|
17.5%
7/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood alkaline phosphatase increased
|
15.0%
6/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood lactate dehydrogenase increased
|
15.0%
6/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Platelet count decreased
|
15.0%
6/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Protein total decreased
|
15.0%
6/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
5/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood urea increased
|
10.0%
4/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.0%
4/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Aspartate aminotransferase increased
|
7.5%
3/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
White blood cell count increased
|
7.5%
3/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood amylase increased
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood bilirubin increased
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood chloride decreased
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood urine present
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
65.0%
26/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
32.5%
13/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
30.0%
12/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
17.5%
7/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.0%
6/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
5/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
4/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
5.0%
2/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Hypertension
|
10.0%
4/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
15.0%
6/40 • Time from first dose up to 30 days after the last dose of study treatment or clinical cut-off date (14 August 2012) or date of death whichever is earlier.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60