Trial Outcomes & Findings for A Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC) (NCT NCT02657369)
NCT ID: NCT02657369
Last Updated: 2019-10-15
Results Overview
ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator review using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for target lesions. CR was defined as disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameters of target lesions, taking as reference the Baseline sum diameters. Confirmation of CR or PR was performed at least 28 days following the initial achievement of the response.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
From the date of beginning of lenvatinib administration to the date of first documentation of disease progression or death, whichever occurred first (up to Month 27)
Results posted on
2019-10-15
Participant Flow
Participants took part in the study at 13 investigative sites in France, Italy, United Kingdom, Australia and the United States from 07 July 2016 to 26 September 2018.
A total of 48 participants were screened, of which 14 were screen failures and 34 were enrolled to receive study treatment.
Participant milestones
| Measure |
Lenvatinib 24 mg
Participants received lenvatinib 24 milligram (mg) (two 10-mg capsules and one 4-mg capsule), orally, once daily in a 28-days treatment cycle up to disease progression, development of unacceptable toxicity, lost to follow up, withdrawal of consent, participant's choice, pregnancy, or study termination by sponsor (approximately 27 months).
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
Lenvatinib 24 mg
Participants received lenvatinib 24 milligram (mg) (two 10-mg capsules and one 4-mg capsule), orally, once daily in a 28-days treatment cycle up to disease progression, development of unacceptable toxicity, lost to follow up, withdrawal of consent, participant's choice, pregnancy, or study termination by sponsor (approximately 27 months).
|
|---|---|
|
Overall Study
Death
|
27
|
|
Overall Study
Study terminated by sponsor
|
7
|
Baseline Characteristics
A Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)
Baseline characteristics by cohort
| Measure |
Lenvatinib 24 mg
n=34 Participants
Participants received lenvatinib 24 mg (two 10-mg capsules and one 4-mg capsule), orally, once daily in a 28-days treatment cycle up to disease progression, development of unacceptable toxicity, lost to follow up, withdrawal of consent, participant's choice, pregnancy, or study termination by sponsor (approximately 27 months).
|
|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 10.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of beginning of lenvatinib administration to the date of first documentation of disease progression or death, whichever occurred first (up to Month 27)Population: The evaluable analysis set included all participants with histological diagnosis of ATC that was confirmed by central pathology review and who received at least one dose of lenvatinib.
ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator review using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for target lesions. CR was defined as disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameters of target lesions, taking as reference the Baseline sum diameters. Confirmation of CR or PR was performed at least 28 days following the initial achievement of the response.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=33 Participants
Participants received lenvatinib 24 mg (two 10-mg capsules and one 4-mg capsule), orally, once daily in a 28-days treatment cycle up to disease progression, development of unacceptable toxicity, lost to follow up, withdrawal of consent, participant's choice, pregnancy, or study termination by sponsor (approximately 27 months).
|
|---|---|
|
Objective Response Rate (ORR)
|
3.0 percentage of participants
Interval 0.1 to 15.8
|
SECONDARY outcome
Timeframe: From the date of beginning of lenvatinib administration up to the date of first documentation of confirmed disease progression or death, whichever occurred first (up to Week 12)Population: The full analysis set included all participants who received at least one dose of lenvatinib.
Twelve-week PFS rate was the percentage of participants in the analysis population who remain alive and progression-free at 12 weeks. PFS was defined as the time from the date of beginning of lenvatinib administration to the date of first documentation of confirmed disease progression or death, whichever occurred first. The Kaplan-Meier estimated rate method was used to estimate 12-week PFS, along with the corresponding 95% confidence interval (CI). Participants who were off study due to lost to follow up, withdrew consent, or study terminated by sponsor, had new anti-cancer treatment, had no baseline/post-baseline tumor assessments, or missed 2 or more visits prior to event were censored.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=34 Participants
Participants received lenvatinib 24 mg (two 10-mg capsules and one 4-mg capsule), orally, once daily in a 28-days treatment cycle up to disease progression, development of unacceptable toxicity, lost to follow up, withdrawal of consent, participant's choice, pregnancy, or study termination by sponsor (approximately 27 months).
|
|---|---|
|
Progression-free Survival (PFS) Rate
|
36.4 percentage of participants
Interval 20.6 to 52.3
|
SECONDARY outcome
Timeframe: From the date of beginning of lenvatinib administration up to date of death from any cause (up to Month 6)Population: The full analysis set included all participants who received at least one dose of lenvatinib.
Six-month OS rate was defined as the percentage of participants in the analysis population who are alive at 6 months. OS was defined as the time from the date of beginning of lenvatinib administration until date of death from any cause. The Kaplan-Meier estimated rate method was used to estimate six-month OS, along with the corresponding 95% CI. Participants with last known alive date as study terminated by sponsor were censored.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=34 Participants
Participants received lenvatinib 24 mg (two 10-mg capsules and one 4-mg capsule), orally, once daily in a 28-days treatment cycle up to disease progression, development of unacceptable toxicity, lost to follow up, withdrawal of consent, participant's choice, pregnancy, or study termination by sponsor (approximately 27 months).
|
|---|---|
|
Overall Survival (OS) Rate
|
41.2 percentage of participants
Interval 24.8 to 56.9
|
SECONDARY outcome
Timeframe: From the date of beginning of lenvatinib administration to the date of first documentation of confirmed disease progression or death, whichever occurred first (up to Month 27)Population: The full analysis set included all participants who received at least one dose of lenvatinib.
PFS was defined as the time from the date of beginning of lenvatinib administration to the date of first documentation of confirmed disease progression or death, whichever occurs first. Median PFS was estimated using the Kaplan-Meier method. Participants who were off study due to lost to follow up, withdrew consent, or study terminated by sponsor, had new anti-cancer treatment, had no baseline/post-baseline tumor assessments, or missed 2 or more visits prior to event were censored.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=34 Participants
Participants received lenvatinib 24 mg (two 10-mg capsules and one 4-mg capsule), orally, once daily in a 28-days treatment cycle up to disease progression, development of unacceptable toxicity, lost to follow up, withdrawal of consent, participant's choice, pregnancy, or study termination by sponsor (approximately 27 months).
|
|---|---|
|
Median PFS
|
2.6 months
Interval 1.4 to 2.8
|
SECONDARY outcome
Timeframe: From the date of beginning of lenvatinib administration up to date of death from any cause (up to Month 27)Population: The full analysis set included all participants who received at least one dose of lenvatinib.
OS was defined as the time from the date of beginning of lenvatinib administration until date of death from any cause. Median OS was estimated using the Kaplan-Meier method. Participants with last known alive date as study terminated by sponsor were censored.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=34 Participants
Participants received lenvatinib 24 mg (two 10-mg capsules and one 4-mg capsule), orally, once daily in a 28-days treatment cycle up to disease progression, development of unacceptable toxicity, lost to follow up, withdrawal of consent, participant's choice, pregnancy, or study termination by sponsor (approximately 27 months).
|
|---|---|
|
Median OS
|
3.2 months
Interval 2.8 to 8.2
|
Adverse Events
Lenvatinib
Serious events: 25 serious events
Other events: 32 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Lenvatinib
n=34 participants at risk
Participants received lenvatinib 24 mg (two 10-mg capsules and one 4-mg capsule), orally, once daily in a 28-days treatment cycle up to disease progression, development of unacceptable toxicity, lost to follow up, withdrawal of consent, participant's choice, pregnancy, or study termination by sponsor (approximately 27 months).
|
|---|---|
|
Vascular disorders
Deep vein thrombosis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Vascular disorders
Hypertension
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
29.4%
10/34 • Number of events 10 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
General disorders
Asthenia
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
General disorders
Chest pain
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
General disorders
Non-cardiac chest pain
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
General disorders
Pyrexia
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Psychiatric disorders
Confusional state
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Cardiac disorders
Cardiopulmonary failure
|
2.9%
1/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Blood and lymphatic system disorders
Abdominal lymphadenopathy
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.8%
4/34 • Number of events 4 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
1/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.8%
3/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.9%
1/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Nervous system disorders
Presyncope
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Anal fistula
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
2/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Odynophagia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Pancreatitis
|
2.9%
1/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Renal and urinary disorders
Renal failure
|
2.9%
1/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Abscess neck
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Anal abscess
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Arthritis infective
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Bacterial sepsis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Perirectal abscess
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Pyelitis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Septic shock
|
2.9%
1/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
Other adverse events
| Measure |
Lenvatinib
n=34 participants at risk
Participants received lenvatinib 24 mg (two 10-mg capsules and one 4-mg capsule), orally, once daily in a 28-days treatment cycle up to disease progression, development of unacceptable toxicity, lost to follow up, withdrawal of consent, participant's choice, pregnancy, or study termination by sponsor (approximately 27 months).
|
|---|---|
|
Vascular disorders
Bloody discharge
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Vascular disorders
Hypertension
|
52.9%
18/34 • Number of events 34 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Vascular disorders
Hypotension
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Vascular disorders
Inferior vena cava dilatation
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Vascular disorders
Vena cava thrombosis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
2.9%
1/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Immune system disorders
Contrast media reaction
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
General disorders
Asthenia
|
14.7%
5/34 • Number of events 8 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
General disorders
Cyst
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
General disorders
Facial pain
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
General disorders
Fatigue
|
32.4%
11/34 • Number of events 14 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
General disorders
Injection site bruising
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
General disorders
Localised oedema
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
General disorders
Malaise
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
General disorders
Mucosal inflammation
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
General disorders
Oedema peripheral
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
General disorders
Pain
|
5.9%
2/34 • Number of events 4 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Psychiatric disorders
Anxiety
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Psychiatric disorders
Depressed mood
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Psychiatric disorders
Depression
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Psychiatric disorders
Insomnia
|
8.8%
3/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Injury, poisoning and procedural complications
Contusion
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
2/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Aspartate aminotransferase increased
|
8.8%
3/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Bilirubin conjugated increased
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Blood alkaline phosphatase increased
|
8.8%
3/34 • Number of events 4 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Blood bilirubin increased
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Blood creatinine increased
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Blood phosphorus increased
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Blood thyroid stimulating hormone increased
|
8.8%
3/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
C-reactive protein increased
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Electrocardiogram QT prolonged
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.9%
2/34 • Number of events 4 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
International normalised ratio increased
|
8.8%
3/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Liver function test abnormal
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Lymphocyte count decreased
|
11.8%
4/34 • Number of events 5 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Oxygen saturation decreased
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Platelet count decreased
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Sputum normal
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Troponin increased
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Urine analysis abnormal
|
2.9%
1/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Urine leukocyte esterase positive
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
Weight decreased
|
26.5%
9/34 • Number of events 12 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Investigations
White blood cell count decreased
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Cardiac disorders
Acute myocardial infarction
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Cardiac disorders
Atrial tachycardia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Cardiac disorders
Hyperdynamic left ventricle
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Cardiac disorders
Sinus tachycardia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
4/34 • Number of events 5 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
14.7%
5/34 • Number of events 8 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.8%
4/34 • Number of events 5 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.8%
4/34 • Number of events 5 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
17.6%
6/34 • Number of events 8 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
17.6%
6/34 • Number of events 10 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
5.9%
2/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.9%
2/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Nervous system disorders
Amnesia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Nervous system disorders
Cervical radiculopathy
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Nervous system disorders
Dizziness
|
11.8%
4/34 • Number of events 4 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Nervous system disorders
Dysgeusia
|
8.8%
3/34 • Number of events 5 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Nervous system disorders
Facial paralysis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Nervous system disorders
Headache
|
14.7%
5/34 • Number of events 6 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Nervous system disorders
Hyperaesthesia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Nervous system disorders
Hypoaesthesia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Nervous system disorders
Jugular vein occlusion
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Nervous system disorders
Lethargy
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Nervous system disorders
Somnolence
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Nervous system disorders
Syncope
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Nervous system disorders
Tremor
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Eye disorders
Vision blurred
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Ear and labyrinth disorders
Ear pain
|
8.8%
3/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Ear and labyrinth disorders
Vertigo
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Abdominal distension
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Abdominal pain
|
8.8%
3/34 • Number of events 5 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
2/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Anal fistula
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Constipation
|
20.6%
7/34 • Number of events 8 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Dental caries
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Diarrhoea
|
23.5%
8/34 • Number of events 13 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Diverticulum
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Dry mouth
|
8.8%
3/34 • Number of events 4 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Dyspepsia
|
8.8%
3/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Dysphagia
|
20.6%
7/34 • Number of events 10 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Gingival pain
|
5.9%
2/34 • Number of events 4 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Gingival recession
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Glossodynia
|
5.9%
2/34 • Number of events 6 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Loose tooth
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Mouth swelling
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Nausea
|
32.4%
11/34 • Number of events 17 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Odynophagia
|
5.9%
2/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Oral pain
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Pancreatitis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Periodontal disease
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Proctalgia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Stomatitis
|
29.4%
10/34 • Number of events 13 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Tongue dry
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Gastrointestinal disorders
Vomiting
|
17.6%
6/34 • Number of events 9 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Renal and urinary disorders
Haematuria
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Renal and urinary disorders
Proteinuria
|
23.5%
8/34 • Number of events 15 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Renal and urinary disorders
Pyelocaliectasis
|
2.9%
1/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Hepatobiliary disorders
Cholecystitis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Hepatobiliary disorders
Cholestasis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Hepatobiliary disorders
Gallbladder enlargement
|
2.9%
1/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Skin and subcutaneous tissue disorders
Macule
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
23.5%
8/34 • Number of events 9 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
2/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
2/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.9%
1/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.6%
6/34 • Number of events 8 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
4/34 • Number of events 5 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.8%
4/34 • Number of events 4 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.8%
4/34 • Number of events 5 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Endocrine disorders
Hypothyroidism
|
17.6%
6/34 • Number of events 6 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
29.4%
10/34 • Number of events 12 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
8.8%
3/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.7%
5/34 • Number of events 5 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.9%
2/34 • Number of events 4 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.8%
3/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
26.5%
9/34 • Number of events 15 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Metabolism and nutrition disorders
Hypophagia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Arthritis infective
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Oral candidiasis
|
8.8%
3/34 • Number of events 3 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Paronychia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Perirectal abscess
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Sepsis
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Superinfection
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Tooth infection
|
2.9%
1/34 • Number of events 1 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
2/34 • Number of events 2 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
|
Infections and infestations
Urinary tract infection
|
11.8%
4/34 • Number of events 4 • From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place