Trial Outcomes & Findings for Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC (NCT NCT01933932)
NCT ID: NCT01933932
Last Updated: 2025-11-19
Results Overview
Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
510 participants
Primary outcome timeframe
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Results posted on
2025-11-19
Participant Flow
This study started with an assessment visit where a tumour KRAS mutation assessment was performed, eligibility assessments were performed and informed consent obtained. Eligible patients were randomised at the next visit. Patients then received double-blinded study treatment, were seen and assessments performed until objective disease progression.
Eligible patients randomised in a ratio of 1:1 to receive selumetinib (AZD6244; ARRY-142886) 75 mg bd in combination with docetaxel 75 mg/m2 or placebo in combination with docetaxel 75 mg/m2. They were stratified based on their WHO performance status and tumour histology. 510 patients enrolled and 510 randomised.
Participant milestones
| Measure |
Selumetinib + Docetaxel
Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
|
Placebo + Docetaxel
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
254
|
256
|
|
Overall Study
COMPLETED
|
70
|
78
|
|
Overall Study
NOT COMPLETED
|
184
|
178
|
Reasons for withdrawal
| Measure |
Selumetinib + Docetaxel
Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
|
Placebo + Docetaxel
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
|
|---|---|---|
|
Overall Study
Death
|
173
|
163
|
|
Overall Study
Withdrawal by Subject
|
11
|
14
|
|
Overall Study
Eligibility criteria not fulfilled
|
0
|
1
|
Baseline Characteristics
Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC
Baseline characteristics by cohort
| Measure |
Selumetinib + Docetaxel
n=254 Participants
Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
|
Placebo + Docetaxel
n=256 Participants
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
|
Total
n=510 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.9 Years
STANDARD_DEVIATION 8.48 • n=39 Participants
|
60.9 Years
STANDARD_DEVIATION 8.08 • n=29 Participants
|
61.4 Years
STANDARD_DEVIATION 8.30 • n=60 Participants
|
|
Age, Customized
>=65 years
|
97 Participants
n=39 Participants
|
83 Participants
n=29 Participants
|
180 Participants
n=60 Participants
|
|
Age, Customized
<65 years
|
157 Participants
n=39 Participants
|
173 Participants
n=29 Participants
|
330 Participants
n=60 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=39 Participants
|
111 Participants
n=29 Participants
|
207 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
158 Participants
n=39 Participants
|
145 Participants
n=29 Participants
|
303 Participants
n=60 Participants
|
|
Race
White
|
241 Participants
n=39 Participants
|
243 Participants
n=29 Participants
|
484 Participants
n=60 Participants
|
|
Race
Black or African American
|
5 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
6 Participants
n=60 Participants
|
|
Race
Asian
|
1 Participants
n=39 Participants
|
4 Participants
n=29 Participants
|
5 Participants
n=60 Participants
|
|
Race
American Indian or Alaska Native
|
3 Participants
n=39 Participants
|
2 Participants
n=29 Participants
|
5 Participants
n=60 Participants
|
|
Race
Other
|
4 Participants
n=39 Participants
|
6 Participants
n=29 Participants
|
10 Participants
n=60 Participants
|
|
Ethnic group
Hispanic or Latino
|
14 Participants
n=39 Participants
|
15 Participants
n=29 Participants
|
29 Participants
n=60 Participants
|
|
Ethnic group
Not Hispanic or Latino
|
240 Participants
n=39 Participants
|
241 Participants
n=29 Participants
|
481 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)Population: Full analysis set (FAS) population comprised of all randomised patients.
Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Outcome measures
| Measure |
Selumetinib + Docetaxel
n=254 Participants
Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
|
Placebo + Docetaxel
n=256 Participants
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
3.9 Months
Interval 1.5 to 5.9
|
2.8 Months
Interval 1.4 to 5.5
|
SECONDARY outcome
Timeframe: Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSIPopulation: Full analysis set (FAS) population comprised of all randomised patients.
Overall Survival is defined as the time from the date of randomisation until death due to any cause.
Outcome measures
| Measure |
Selumetinib + Docetaxel
n=254 Participants
Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
|
Placebo + Docetaxel
n=256 Participants
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
|
|---|---|---|
|
Overall Survival (OS)
|
8.7 Months
Interval 3.6 to 16.8
|
7.9 Months
Interval 3.8 to 20.1
|
SECONDARY outcome
Timeframe: Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)Population: Full analysis set (FAS) population comprised of all randomised patients.
ORR is defined as the number (%) of subjects with at least one overall visit response of complete response (CR) or partial response (PR). Per RECIST v1.1 for target lesions and assessed by CT/MRI: CR - disappearance of all target lesions; PR - \>=30% decrease in the sum of the longest diameter of target lesion. (Non-target lesion and new lesion results are also taken into account for the overall visit result)
Outcome measures
| Measure |
Selumetinib + Docetaxel
n=254 Participants
Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
|
Placebo + Docetaxel
n=256 Participants
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
51 Number of responders
|
35 Number of responders
|
SECONDARY outcome
Timeframe: Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)Population: Full analysis set (FAS) population comprised of all randomised patients.
Duration of response is defined as the time from the date of first documented response until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Outcome measures
| Measure |
Selumetinib + Docetaxel
n=51 Participants
Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
|
Placebo + Docetaxel
n=35 Participants
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
|
|---|---|---|
|
Duration of Response (DoR)
|
88.0 Days
Interval 82.0 to 126.0
|
136.0 Days
Interval 86.0 to 169.0
|
SECONDARY outcome
Timeframe: Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)Population: Full analysis set (FAS) patients who have a baseline ASBI score \>= 10
The symptom improvement rate will be defined as the number (%) of patients with two consecutive assessments at least 18 days apart (ie 21 days allowing a visit window of 3 days) which showed a clinically meaningful improvement in symptoms from baseline (defined as a decrease in the ASBI from baseline ≥10). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.
Outcome measures
| Measure |
Selumetinib + Docetaxel
n=205 Participants
Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
|
Placebo + Docetaxel
n=217 Participants
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
|
|---|---|---|
|
Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
|
49 Number of patients with improvements
|
46 Number of patients with improvements
|
SECONDARY outcome
Timeframe: Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)Population: Full analysis set (FAS) patients who have a baseline ASBI score \<= 90
Time to symptom progression will be defined as the time from randomization until the date of first clinically meaningful symptom deterioration (defined as an increase in the ASBI from baseline ≥10), or death (by any cause). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.
Outcome measures
| Measure |
Selumetinib + Docetaxel
n=234 Participants
Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
|
Placebo + Docetaxel
n=247 Participants
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
|
|---|---|---|
|
Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
|
1.6 Months
Interval 0.4 to 4.6
|
1.3 Months
Interval 0.3 to 4.2
|
Adverse Events
Selumetinib + Docetaxel
Serious events: 124 serious events
Other events: 244 other events
Deaths: 0 deaths
Placebo + Docetaxel
Serious events: 82 serious events
Other events: 235 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Selumetinib + Docetaxel
n=251 participants at risk
Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
|
Placebo + Docetaxel
n=254 participants at risk
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.6%
4/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
5/251 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Cardiac failure
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Coronary artery dissection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Pericarditis constrictive
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Sinus bradycardia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Retinal vein thrombosis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Colitis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Constipation
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
10/251 • Number of events 10 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Dysphagia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Proctitis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Subileus
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Asthenia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Euthanasia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Fatigue
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
General physical health deterioration
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Malaise
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Oedema peripheral
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Pyrexia
|
2.8%
7/251 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.0%
5/254 • Number of events 9 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Immune system disorders
Hypersensitivity
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Anal abscess
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Arthritis infective
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Bronchitis
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Device related infection
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Herpes zoster
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Infected skin ulcer
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Infectious pleural effusion
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.40%
1/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Lower respiratory tract infection
|
1.6%
4/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.0%
5/254 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Lung abscess
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Lung infection
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Pneumonia
|
6.8%
17/251 • Number of events 20 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
4.3%
11/254 • Number of events 14 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Pneumonia viral
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Respiratory tract infection
|
2.4%
6/251 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Sepsis
|
2.8%
7/251 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Urinary tract infection
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Urosepsis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
C-reactive protein increased
|
0.80%
2/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Ejection fraction decreased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
6/251 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Dropped head syndrome
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Neurological decompensation
|
0.40%
1/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Polyneuropathy
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Syncope
|
0.80%
2/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
7/251 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.6%
4/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
4/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Deep vein thrombosis
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Hypotension
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Internal haemorrhage
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Superior vena cava syndrome
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Venous thrombosis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
Other adverse events
| Measure |
Selumetinib + Docetaxel
n=251 participants at risk
Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
|
Placebo + Docetaxel
n=254 participants at risk
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
|
|---|---|---|
|
Nervous system disorders
Dysarthria
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Dysgeusia
|
6.8%
17/251 • Number of events 17 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
9.1%
23/254 • Number of events 25 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Facial neuralgia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Headache
|
3.6%
9/251 • Number of events 10 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
10.2%
26/254 • Number of events 30 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Hypoaesthesia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Lethargy
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.0%
5/254 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Memory impairment
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.0%
5/254 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Neuropathy peripheral
|
4.8%
12/251 • Number of events 12 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
3.9%
10/254 • Number of events 10 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Neurotoxicity
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Paraesthesia
|
7.2%
18/251 • Number of events 18 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
6.7%
17/254 • Number of events 23 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Paresis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Parosmia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.6%
9/251 • Number of events 9 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.8%
7/254 • Number of events 9 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Polyneuropathy
|
1.6%
4/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.0%
5/254 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Seizure
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Somnolence
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Syncope
|
2.4%
6/251 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Vocal cord paralysis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Psychiatric disorders
Agitation
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Psychiatric disorders
Anxiety
|
4.0%
10/251 • Number of events 10 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.0%
5/254 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Psychiatric disorders
Confusional state
|
2.0%
5/251 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Psychiatric disorders
Delusion
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Psychiatric disorders
Depression
|
1.6%
4/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Psychiatric disorders
Disorientation
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Psychiatric disorders
Hallucination
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Psychiatric disorders
Illusion
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Psychiatric disorders
Insomnia
|
3.6%
9/251 • Number of events 9 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
3.9%
10/254 • Number of events 11 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Psychiatric disorders
Irritability
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Psychiatric disorders
Panic attack
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Psychiatric disorders
Sleep disorder
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Psychiatric disorders
Stress
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Psychiatric disorders
Tension
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Chromaturia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.40%
1/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Costovertebral angle tenderness
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Dysuria
|
1.6%
4/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Pollakiuria
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Proteinuria
|
0.80%
2/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Renal failure
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Strangury
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Urinary retention
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Urinary tract pain
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Reproductive system and breast disorders
Prostatism
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.40%
1/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.7%
37/251 • Number of events 39 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
13.8%
35/254 • Number of events 44 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.4%
11/251 • Number of events 12 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.8%
7/254 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.9%
55/251 • Number of events 57 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
15.7%
40/254 • Number of events 41 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.4%
6/251 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.8%
7/254 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.2%
13/251 • Number of events 13 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
3.1%
8/254 • Number of events 10 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.2%
8/251 • Number of events 12 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
3.1%
8/254 • Number of events 14 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.80%
2/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
7/251 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
3.1%
8/254 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural disorder
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.4%
11/251 • Number of events 14 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
3.5%
9/254 • Number of events 12 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.2%
8/251 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
3.9%
10/254 • Number of events 11 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.0%
5/251 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.4%
6/254 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.8%
7/251 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.5%
49/251 • Number of events 49 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
25.2%
64/254 • Number of events 65 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
12.0%
30/251 • Number of events 34 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.0%
30/251 • Number of events 31 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
5.5%
14/254 • Number of events 19 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.80%
2/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.8%
7/251 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
3.1%
8/254 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.6%
4/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Nail bed disorder
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
3.2%
8/251 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.0%
5/254 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
1.6%
4/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
4.8%
12/251 • Number of events 12 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.8%
7/254 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.8%
7/251 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.4%
16/251 • Number of events 21 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
4.7%
12/254 • Number of events 12 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.80%
2/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.9%
85/251 • Number of events 114 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
11.0%
28/254 • Number of events 29 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
2.8%
7/251 • Number of events 10 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
1.6%
4/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
2.8%
7/251 • Number of events 10 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.2%
8/251 • Number of events 9 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
2.0%
5/251 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Blood and lymphatic system disorders
Anaemia
|
18.3%
46/251 • Number of events 50 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
14.6%
37/254 • Number of events 40 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.8%
7/251 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.0%
5/251 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.8%
22/251 • Number of events 24 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
5.5%
14/254 • Number of events 15 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
5/251 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Bradycardia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Bundle branch block left
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Cardiac failure
|
2.0%
5/251 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Diastolic dysfunction
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Mitral valve incompetence
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Palpitations
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Cardiac disorders
Tachycardia
|
1.6%
4/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.8%
7/254 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Ear and labyrinth disorders
Deafness
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Ear and labyrinth disorders
Ear pain
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Ear and labyrinth disorders
Vertigo
|
3.2%
8/251 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.4%
6/254 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Endocrine disorders
Goitre
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Endocrine disorders
Oestrogen deficiency
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Cataract
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Chorioretinopathy
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Conjunctival irritation
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Conjunctivitis allergic
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Diplopia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Dry eye
|
1.6%
4/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Eye discharge
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Eye irritation
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Eye pain
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Eyelid oedema
|
4.0%
10/251 • Number of events 10 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Eyelid skin dryness
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Hypermetropia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Keratitis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Lacrimation increased
|
6.4%
16/251 • Number of events 16 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
5.1%
13/254 • Number of events 13 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Macular oedema
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Ocular hyperaemia
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Ocular icterus
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Optic nerve compression
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Periorbital oedema
|
4.4%
11/251 • Number of events 11 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Photopsia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Presbyopia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Retinal vein thrombosis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Retinopathy
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Ulcerative keratitis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Vision blurred
|
3.2%
8/251 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Visual acuity reduced
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Eye disorders
Visual impairment
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Abdominal distension
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Abdominal pain
|
9.2%
23/251 • Number of events 25 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
7.5%
19/254 • Number of events 25 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
12/251 • Number of events 13 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
4.3%
11/254 • Number of events 12 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Anal fissure
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Anal haemorrhage
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Anal inflammation
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Ascites
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Colitis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Constipation
|
15.5%
39/251 • Number of events 43 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
18.5%
47/254 • Number of events 57 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Diarrhoea
|
59.4%
149/251 • Number of events 234 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
33.9%
86/254 • Number of events 126 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Diverticulum
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Dry mouth
|
6.0%
15/251 • Number of events 16 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
14/251 • Number of events 14 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
4.7%
12/254 • Number of events 14 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Dysphagia
|
3.2%
8/251 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.0%
5/254 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Enteritis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Flatulence
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Gastritis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.2%
8/251 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Glossodynia
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Haematochezia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Lip blister
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Lip dry
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Melaena
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.6%
4/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Nausea
|
37.5%
94/251 • Number of events 117 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
24.4%
62/254 • Number of events 81 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Oral discomfort
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Oral pain
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Stomatitis
|
25.9%
65/251 • Number of events 82 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
13.0%
33/254 • Number of events 38 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Swollen tongue
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Tooth loss
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Toothache
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Gastrointestinal disorders
Vomiting
|
25.5%
64/251 • Number of events 87 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
12.2%
31/254 • Number of events 40 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Asthenia
|
26.3%
66/251 • Number of events 76 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
18.1%
46/254 • Number of events 54 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Catheter site inflammation
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Chest pain
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Chills
|
2.4%
6/251 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Device failure
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Extravasation
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Face oedema
|
8.8%
22/251 • Number of events 26 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Fatigue
|
27.5%
69/251 • Number of events 97 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
30.7%
78/254 • Number of events 96 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Feeling cold
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Feeling hot
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Gait disturbance
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
General physical health deterioration
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Generalised oedema
|
3.2%
8/251 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Hyperthermia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Inflammation
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Inflammatory pain
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Influenza like illness
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
3.5%
9/254 • Number of events 10 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Infusion site extravasation
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Injection site pruritus
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Injection site reaction
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Local swelling
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Localised oedema
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Malaise
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Mucosal inflammation
|
3.6%
9/251 • Number of events 10 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Mucosal toxicity
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Nodule
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Non-cardiac chest pain
|
2.8%
7/251 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.0%
5/254 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Oedema
|
5.2%
13/251 • Number of events 14 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.8%
7/254 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Oedema peripheral
|
29.9%
75/251 • Number of events 98 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
15.0%
38/254 • Number of events 40 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Pain
|
3.6%
9/251 • Number of events 10 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Performance status decreased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Peripheral swelling
|
2.4%
6/251 • Number of events 9 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Pyrexia
|
18.7%
47/251 • Number of events 62 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
12.2%
31/254 • Number of events 42 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Soft tissue inflammation
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Temperature intolerance
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Tenderness
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
General disorders
Xerosis
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Hepatobiliary disorders
Cholestasis
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Hepatobiliary disorders
Hepatic pain
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.40%
1/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Hepatobiliary disorders
Jaundice
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Immune system disorders
Contrast media allergy
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Immune system disorders
Drug hypersensitivity
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Immune system disorders
Iodine allergy
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Anal abscess
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Anal fungal infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Anal infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Angular cheilitis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Aspergillus infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Bacteriuria
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Breast abscess
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Bronchitis
|
3.2%
8/251 • Number of events 9 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.8%
7/254 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Bullous impetigo
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Candida infection
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Cellulitis
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Conjunctivitis
|
4.8%
12/251 • Number of events 13 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.0%
5/254 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Cystitis
|
1.2%
3/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.4%
6/254 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Device related infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Ear infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Erysipelas
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Eye infection
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Folliculitis
|
1.6%
4/251 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Fungal infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Fungal oesophagitis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Fungal skin infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Gastroenteritis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Genital infection
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Gingivitis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Herpes virus infection
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Herpes zoster
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Hordeolum
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Impetigo
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Infected dermal cyst
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Influenza
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Injection site infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Localised infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.8%
7/254 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Lung infection
|
2.0%
5/251 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.0%
5/254 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
10/251 • Number of events 12 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.8%
7/254 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Onychomycosis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Oral candidiasis
|
2.0%
5/251 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.0%
5/254 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Oral fungal infection
|
1.6%
4/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Oral herpes
|
1.2%
3/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Oral infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Oropharyngitis fungal
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Otitis externa
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Otitis media
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Paronychia
|
5.6%
14/251 • Number of events 14 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.4%
6/254 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Pharyngitis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Pneumonia
|
3.2%
8/251 • Number of events 11 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Pneumonia bacterial
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Rash pustular
|
2.4%
6/251 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Respiratory tract infection
|
3.6%
9/251 • Number of events 10 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
3.1%
8/254 • Number of events 10 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Respiratory tract infection viral
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Rhinitis
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Sepsis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Sialoadenitis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Sinusitis
|
2.4%
6/251 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.0%
5/254 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Skin candida
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Skin infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Staphylococcal infection
|
0.40%
1/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Tonsillitis
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Tonsillitis bacterial
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Tooth abscess
|
0.40%
1/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
3.1%
8/254 • Number of events 11 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Urinary tract infection
|
6.4%
16/251 • Number of events 21 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.4%
6/254 • Number of events 11 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Urosepsis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Vaginal infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Viral infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Viral pharyngitis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Epiphyseal fracture
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
4/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Pulmonary radiation injury
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Venous injury
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Injury, poisoning and procedural complications
Wound
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
6/251 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.0%
5/254 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
6/251 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Blood albumin decreased
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Blood bilirubin increased
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Blood calcium increased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.40%
1/251 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Blood creatine phosphokinase increased
|
2.4%
6/251 • Number of events 9 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Blood creatinine increased
|
2.4%
6/251 • Number of events 10 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Blood glucose increased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Blood potassium decreased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Blood pressure decreased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Blood pressure increased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Blood pressure systolic decreased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Blood urea increased
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Body temperature increased
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
C-reactive protein increased
|
2.8%
7/251 • Number of events 9 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Carcinoembryonic antigen increased
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Eastern Cooperative Oncology Group performance status worsened
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Ejection fraction decreased
|
2.0%
5/251 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.4%
6/251 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.4%
6/254 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Inspiratory capacity decreased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
International normalised ratio increased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Neutrophil count decreased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Neutrophil count increased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Oxygen saturation decreased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Platelet count decreased
|
1.2%
3/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Platelet count increased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Protein total decreased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Transaminases increased
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Troponin I increased
|
0.40%
1/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Troponin increased
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Urine output decreased
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Weight decreased
|
8.4%
21/251 • Number of events 21 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
4.3%
11/254 • Number of events 12 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
Weight increased
|
2.8%
7/251 • Number of events 7 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Investigations
White blood cell count increased
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.3%
56/251 • Number of events 68 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
23.6%
60/254 • Number of events 76 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Dehydration
|
4.4%
11/251 • Number of events 12 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.4%
6/254 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.80%
2/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Hyperproteinaemia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.6%
9/251 • Number of events 11 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.0%
5/251 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.40%
1/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.4%
11/251 • Number of events 11 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.4%
6/254 • Number of events 10 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.4%
11/251 • Number of events 11 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.80%
2/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Amyotrophy
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.2%
23/251 • Number of events 24 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
7.5%
19/254 • Number of events 23 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.6%
19/251 • Number of events 22 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
11.0%
28/254 • Number of events 32 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.2%
18/251 • Number of events 23 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
7.9%
20/254 • Number of events 21 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Fistula discharge
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.8%
7/254 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.0%
10/251 • Number of events 10 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.8%
7/254 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.4%
11/251 • Number of events 11 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
4.7%
12/254 • Number of events 12 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
5/251 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
5.1%
13/254 • Number of events 15 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.2%
23/251 • Number of events 24 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
14.6%
37/254 • Number of events 49 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.6%
4/251 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.0%
5/254 • Number of events 6 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
9/251 • Number of events 11 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
5.9%
15/254 • Number of events 20 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Rheumatic disorder
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial sarcoma
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Ageusia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Amnesia
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Aphonia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Apraxia
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Burning sensation
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Cerebellar syndrome
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Disturbance in attention
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Dizziness
|
6.0%
15/251 • Number of events 15 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
3.9%
10/254 • Number of events 11 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Deep vein thrombosis
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Embolism
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Flushing
|
1.2%
3/251 • Number of events 3 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.79%
2/254 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Haematoma
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.6%
4/254 • Number of events 4 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Haemorrhage
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Hot flush
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
2.0%
5/254 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Hypertension
|
1.6%
4/251 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
1.2%
3/254 • Number of events 5 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Hypotension
|
5.2%
13/251 • Number of events 16 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
3.1%
8/254 • Number of events 8 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Inferior vena cava syndrome
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Lymphoedema
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Orthostatic hypotension
|
0.80%
2/251 • Number of events 2 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Peripheral coldness
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Phlebitis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Thrombosis
|
0.00%
0/251 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.39%
1/254 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Varicose vein
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
|
Vascular disorders
Vena cava thrombosis
|
0.40%
1/251 • Number of events 1 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
0.00%
0/254 • AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.
The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).
|
Additional Information
Dr Gabriella Mariani
AstraZeneca Research and Development
Phone: +44 (0)1763 263801
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place