Trial Outcomes & Findings for Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer (NCT NCT00678535)
NCT ID: NCT00678535
Last Updated: 2014-07-21
Results Overview
The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event are censored on the date of last tumor assessment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
904 participants
Primary outcome timeframe
Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
Results posted on
2014-07-21
Participant Flow
First/last participant (informed consent): June 2008/December 2010. Clinical data cut-off: 31 March 2012 Study completion 17 February 2013.
Enrolled: 1,191 screened for eligibility; 287 excluded (mainly non-fulfillment of inclusion or exclusion criteria). 904 participants randomized.
Participant milestones
| Measure |
Cetuximab Plus Capecitabine Plus Cisplatin
Cetuximab weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by 250 mg/m\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
Capecitabine Plus Cisplatin
Cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Overall Study
STARTED
|
455
|
449
|
|
Overall Study
COMPLETED
|
362
|
351
|
|
Overall Study
NOT COMPLETED
|
93
|
98
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer
Baseline characteristics by cohort
| Measure |
Cetuximab Plus Capecitabine Plus Cisplatin
n=455 Participants
Cetuximab weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by 250 mg/m\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
Capecitabine Plus Cisplatin
n=449 Participants
Cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
Total
n=904 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 11.16 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 10.83 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 11.00 • n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
339 Participants
n=5 Participants
|
334 Participants
n=7 Participants
|
673 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)Population: Intent-to-treat (ITT) population included all participants who were randomized to trial treatment.
The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event are censored on the date of last tumor assessment.
Outcome measures
| Measure |
Cetuximab Plus Capecitabine Plus Cisplatin
n=455 Participants
Cetuximab weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by 250 mg/m\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
Capecitabine Plus Cisplatin
n=449 Participants
Cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments
|
4.4 months
Interval 4.2 to 5.5
|
5.6 months
Interval 5.1 to 5.7
|
SECONDARY outcome
Timeframe: Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)Population: ITT population included all participants who were randomized to trial treatment.
The OS time is defined as the time from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Outcome measures
| Measure |
Cetuximab Plus Capecitabine Plus Cisplatin
n=455 Participants
Cetuximab weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by 250 mg/m\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
Capecitabine Plus Cisplatin
n=449 Participants
Cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Overall Survival (OS)
|
9.4 months
Interval 8.3 to 10.6
|
10.7 months
Interval 9.4 to 11.3
|
SECONDARY outcome
Timeframe: Every 6 weeks until progression, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)Population: ITT population included all participants who were randomized to trial treatment.
The BOR rate is defined as the percentage of participants having achieved complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors \[RECIST\] Version 1.0) from the IRC.
Outcome measures
| Measure |
Cetuximab Plus Capecitabine Plus Cisplatin
n=455 Participants
Cetuximab weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by 250 mg/m\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
Capecitabine Plus Cisplatin
n=449 Participants
Cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments
|
29.9 percentage of participants
Interval 25.7 to 34.3
|
29.2 percentage of participants
Interval 25.0 to 33.6
|
SECONDARY outcome
Timeframe: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)Population: Analysis population included participants who had at least one evaluable EORTC QLQ-C30 questionnaire and were also included in the ITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
Mean global health status and social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.
Outcome measures
| Measure |
Cetuximab Plus Capecitabine Plus Cisplatin
n=450 Participants
Cetuximab weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by 250 mg/m\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
Capecitabine Plus Cisplatin
n=430 Participants
Cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Global health status: Week 18
|
60.45 units on a scale
Standard Deviation 20.015
|
61.83 units on a scale
Standard Deviation 21.499
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Global health status: Week 24
|
62.46 units on a scale
Standard Deviation 22.978
|
63.61 units on a scale
Standard Deviation 19.477
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Global health status: Week 42
|
59.29 units on a scale
Standard Deviation 21.558
|
62.64 units on a scale
Standard Deviation 22.005
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Global health status: Week 48
|
63.39 units on a scale
Standard Deviation 21.317
|
66.67 units on a scale
Standard Deviation 19.395
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Global health status: Week 54
|
60.63 units on a scale
Standard Deviation 16.198
|
66.67 units on a scale
Standard Deviation 14.651
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social functioning status: Baseline
|
74.36 units on a scale
Standard Deviation 27.077
|
76.52 units on a scale
Standard Deviation 26.601
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social functioning status at Week 48
|
80.36 units on a scale
Standard Deviation 22.705
|
78.00 units on a scale
Standard Deviation 23.432
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social functioning status: Week 6
|
68.94 units on a scale
Standard Deviation 28.885
|
75.70 units on a scale
Standard Deviation 27.415
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social functioning status: Week 12
|
71.48 units on a scale
Standard Deviation 26.547
|
75.65 units on a scale
Standard Deviation 27.691
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social functioning status: Week 18
|
71.22 units on a scale
Standard Deviation 25.317
|
75.51 units on a scale
Standard Deviation 25.612
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social functioning status: Week 24
|
74.20 units on a scale
Standard Deviation 26.143
|
78.26 units on a scale
Standard Deviation 27.633
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social functioning status: Week 30
|
78.51 units on a scale
Standard Deviation 24.766
|
76.67 units on a scale
Standard Deviation 24.962
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social functioning status: Week 36
|
76.28 units on a scale
Standard Deviation 21.730
|
73.58 units on a scale
Standard Deviation 22.353
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social functioning status: Week 42
|
68.57 units on a scale
Standard Deviation 27.348
|
78.16 units on a scale
Standard Deviation 22.318
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social functioning status: Week 54
|
74.71 units on a scale
Standard Deviation 27.682
|
80.56 units on a scale
Standard Deviation 27.371
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social functioning status: Week 60
|
78.33 units on a scale
Standard Deviation 23.632
|
68.06 units on a scale
Standard Deviation 32.144
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Global health status: Baseline
|
57.49 units on a scale
Standard Deviation 22.168
|
57.19 units on a scale
Standard Deviation 22.124
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Global health status: Week 6
|
59.00 units on a scale
Standard Deviation 21.879
|
61.80 units on a scale
Standard Deviation 22.089
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Global health status: Week 12
|
60.17 units on a scale
Standard Deviation 20.796
|
63.35 units on a scale
Standard Deviation 22.077
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Global health status: Week 30
|
63.65 units on a scale
Standard Deviation 21.722
|
64.11 units on a scale
Standard Deviation 19.757
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Global health status: Week 36
|
65.06 units on a scale
Standard Deviation 22.629
|
57.72 units on a scale
Standard Deviation 21.602
|
|
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Global health status: Week 60
|
62.50 units on a scale
Standard Deviation 13.918
|
61.81 units on a scale
Standard Deviation 17.210
|
SECONDARY outcome
Timeframe: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)Population: Analysis population included participants who had at least one evaluable EuroQoL EQ-5D questionnaire and were also included in the ITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 single items are combined to obtain a single index score that is health utility index (HUI) score reflecting subject's preferences for different health states. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QoL.
Outcome measures
| Measure |
Cetuximab Plus Capecitabine Plus Cisplatin
n=450 Participants
Cetuximab weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by 250 mg/m\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
Capecitabine Plus Cisplatin
n=430 Participants
Cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire
Baseline
|
0.743 units on a scale
Standard Deviation 0.240
|
0.749 units on a scale
Standard Deviation 0.235
|
|
Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire
Week 6
|
0.739 units on a scale
Standard Deviation 0.276
|
0.769 units on a scale
Standard Deviation 0.254
|
|
Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire
Week 12
|
0.752 units on a scale
Standard Deviation 0.239
|
0.775 units on a scale
Standard Deviation 0.246
|
|
Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire
Week 18
|
0.742 units on a scale
Standard Deviation 0.251
|
0.755 units on a scale
Standard Deviation 0.235
|
|
Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire
Week 24
|
0.733 units on a scale
Standard Deviation 0.300
|
0.761 units on a scale
Standard Deviation 0.265
|
|
Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire
Week 30
|
0.737 units on a scale
Standard Deviation 0.301
|
0.790 units on a scale
Standard Deviation 0.230
|
|
Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire
Week 36
|
0.710 units on a scale
Standard Deviation 0.311
|
0.711 units on a scale
Standard Deviation 0.309
|
|
Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire
Week 42
|
0.722 units on a scale
Standard Deviation 0.209
|
0.689 units on a scale
Standard Deviation 0.307
|
|
Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire
Week 48
|
0.719 units on a scale
Standard Deviation 0.227
|
0.770 units on a scale
Standard Deviation 0.216
|
|
Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire
Week 54
|
0.733 units on a scale
Standard Deviation 0.275
|
0.730 units on a scale
Standard Deviation 0.191
|
|
Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire
Week 60
|
0.760 units on a scale
Standard Deviation 0.322
|
0.742 units on a scale
Standard Deviation 0.170
|
SECONDARY outcome
Timeframe: Time from first dose up to Day 30 after last dose of study treatment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)Population: The safety population included all participants who received at least one dose of any trial treatment that is, cetuximab, cisplatin, or capecitabine.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
Outcome measures
| Measure |
Cetuximab Plus Capecitabine Plus Cisplatin
n=446 Participants
Cetuximab weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by 250 mg/m\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
Capecitabine Plus Cisplatin
n=436 Participants
Cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Safety - Number of Participants With Adverse Events (AEs)
|
446 participants
|
432 participants
|
Adverse Events
Cetuximab Plus Capecitabine Plus Cisplatin
Serious events: 239 serious events
Other events: 441 other events
Deaths: 0 deaths
Capecitabine Plus Cisplatin
Serious events: 194 serious events
Other events: 429 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab Plus Capecitabine Plus Cisplatin
n=446 participants at risk
Cetuximab weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by 250 mg/m\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
Capecitabine Plus Cisplatin
n=436 participants at risk
Cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
10/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
3.9%
17/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
9/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
3.0%
13/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
5/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.1%
5/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.6%
7/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.4%
6/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.90%
4/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Cardiac arrest
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Myocardial infarction
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Atrial fibrillation
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.92%
4/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.69%
3/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Angina pectoris
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Atrial flutter
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Cardiac failure
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Tachycardia
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Ear and labyrinth disorders
Auricular perichondritis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Ear and labyrinth disorders
Vertigo
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Eye disorders
Ocular icterus
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
16/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
5.7%
25/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
15/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
3.4%
15/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
11/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
3.0%
13/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
9/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.4%
6/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Ascites
|
2.0%
9/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.69%
3/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
6/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.69%
3/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Ileus
|
0.90%
4/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.6%
7/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.69%
3/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Subileus
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Melaena
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Constipation
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.1%
5/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Gastrointestinal stenosis
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
General physical health deterioration
|
2.7%
12/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
3.0%
13/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Fatigue
|
2.5%
11/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.1%
5/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Pyrexia
|
1.8%
8/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.6%
7/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Disease progression
|
1.6%
7/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Asthenia
|
1.3%
6/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.1%
5/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Mucosal inflammation
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.69%
3/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Performance status decreased
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.69%
3/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Device dislocation
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Non-cardiac chest pain
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Oedema peripheral
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Device occlusion
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Stent malfunction
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Sudden death
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Chest discomfort
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Death
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Multi-organ failure
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.92%
4/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Pain
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Hepatobiliary disorders
Jaundice
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Immune system disorders
Hypersensitivity
|
0.90%
4/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Immune system disorders
Anaphylactic shock
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Sepsis
|
1.1%
5/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Pneumonia
|
0.90%
4/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.8%
8/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Device related infection
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.92%
4/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Gastroenteritis
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Septic shock
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Paronychia
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Abdominal abscess
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Bacteraemia
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Candida sepsis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Cellulitis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Enterocolitis infectious
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Herpes zoster
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Infection
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Klebsiella sepsis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Liver abscess
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Pneumonia bacterial
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Respiratory tract infection
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Skin infection
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Cystitis
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Gangrene
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Influenza
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood bilirubin increased
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Weight decreased
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Alanine aminotransferase increased
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood creatinine increased
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.1%
5/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood urine
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Electrocardiogram low voltage
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Glomerular filtration rate decreased
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
International normalised ratio increased
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Liver function test abnormal
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Troponin increased
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Platelet count decreased
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Troponin I increased
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.4%
15/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.69%
3/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
9/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
3.4%
15/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.6%
7/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
2.1%
9/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.69%
3/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.92%
4/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to ovary
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour perforation
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour rupture
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Syncope
|
1.3%
6/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.92%
4/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Cerebral infarction
|
1.1%
5/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Ischaemic stroke
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Brain stem infarction
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Dizziness
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.1%
5/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Headache
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Spinal cord compression
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Delirium
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Depression
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Renal failure
|
0.67%
3/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.92%
4/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Renal failure acute
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Haematuria
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Renal colic
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Renal impairment
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Urinary retention
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.8%
26/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
3.0%
13/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
7/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.92%
4/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.90%
4/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.22%
1/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Deep vein thrombosis
|
2.5%
11/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Hypotension
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Peripheral ischaemia
|
0.45%
2/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.46%
2/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
Other adverse events
| Measure |
Cetuximab Plus Capecitabine Plus Cisplatin
n=446 participants at risk
Cetuximab weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by 250 mg/m\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
Capecitabine Plus Cisplatin
n=436 participants at risk
Cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
43.5%
194/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
53.7%
234/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Anaemia
|
28.5%
127/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
35.6%
155/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.2%
81/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
20.4%
89/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.0%
67/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
21.6%
94/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.5%
20/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
5.3%
23/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Nausea
|
61.2%
273/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
60.8%
265/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Diarrhoea
|
38.6%
172/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
24.1%
105/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Vomiting
|
37.0%
165/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
44.0%
192/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Constipation
|
26.9%
120/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
25.2%
110/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Stomatitis
|
22.4%
100/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
9.4%
41/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.6%
92/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
16.5%
72/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.0%
67/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
10.1%
44/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.1%
45/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
4.8%
21/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Dysphagia
|
5.2%
23/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
3.2%
14/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Fatigue
|
41.9%
187/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
37.2%
162/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Asthenia
|
20.6%
92/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
22.5%
98/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Mucosal inflammation
|
14.6%
65/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
7.1%
31/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Pyrexia
|
14.3%
64/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
8.7%
38/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Oedema peripheral
|
6.1%
27/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
6.0%
26/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.6%
25/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
2.5%
11/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Paronychia
|
14.1%
63/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.69%
3/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Weight decreased
|
24.0%
107/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
17.7%
77/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Haemoglobin decreased
|
8.3%
37/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
8.5%
37/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Glomerular filtration rate decreased
|
6.7%
30/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
8.0%
35/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood creatinine increased
|
6.5%
29/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
8.5%
37/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Aspartate aminotransferase increased
|
5.8%
26/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
3.0%
13/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Alanine aminotransferase increased
|
5.4%
24/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
3.7%
16/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Neutrophil count decreased
|
4.5%
20/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
5.0%
22/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Platelet count decreased
|
3.8%
17/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
5.0%
22/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
49.6%
221/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
46.1%
201/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
29.8%
133/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
13.8%
60/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
19.3%
86/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
12.8%
56/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
15.0%
67/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
8.7%
38/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.4%
42/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
7.8%
34/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.7%
39/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
5.5%
24/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
29/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
3.2%
14/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.5%
29/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
3.0%
13/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
35/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
4.4%
19/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Dizziness
|
14.8%
66/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
10.3%
45/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.4%
33/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
6.2%
27/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Dysgeusia
|
7.2%
32/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
6.7%
29/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Headache
|
7.0%
31/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
5.0%
22/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.2%
23/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
9.4%
41/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Paraesthesia
|
4.5%
20/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
6.2%
27/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Insomnia
|
9.2%
41/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
7.3%
32/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
38/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
4.4%
19/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
37/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
4.8%
21/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.5%
29/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
10.8%
47/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Rash
|
43.5%
194/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
5.3%
23/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
36.3%
162/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
22.2%
97/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
17.5%
78/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.6%
56/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
2.5%
11/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Acne
|
12.1%
54/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.3%
28/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
4.4%
19/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
6.3%
28/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.23%
1/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.4%
15/446 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
6.2%
27/436 • Time from first dose up to 30 days after the last dose of study treatment.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER